FDA Registration Active 🇩🇪 Germany

HENKE-SASS WOLF, GMBH.

Reg #: 8010418 · FEI: 3007130719 · Expires 2026
Products
36
Proprietary Names
323
Establishment Types
4
Classifications
36

Registration Details

Registration Name
HENKE-SASS WOLF, GMBH.
Registration Number
8010418
FEI Number
3007130719
Status
Active
Expiry Year
2026
Initial Importer
No
Address
KELTENSTRASSE 1
City
TUTTLINGEN Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K173070

Owner / Operator

Firm Name
HENKE-SASS WOLF, GMBH.
Operator Number
8010418
Address
Keltenstrasse 1, --
City
TUTTLINGEN
State
Baden-Wurttemberg
Postal Code
D-78532
Country
DE

Products

Device Name Product Code
Hysteroscope Accessories NWW
Hysteroscope (And Accessories) HIH
Evacuator, Bladder, Manually Operated FFD
Container, Liquid Medication, Graduated KYW
Tray, Surgical, Instrument FSM
Laparoscope, Gynecologic (And Accessories) HET
Orthopedic Manual Surgical Instrument LXH
Electrode, Electrosurgical, Active, Urological FAS
Cystoscope And Accessories, Flexible/Rigid FAJ
Forceps, General & Plastic Surgery GEN
Laparoscope, General & Plastic Surgery GCJ
Nasopharyngoscope (Flexible Or Rigid) EOB
Endoscope, Neurological GWG
Urethrotome EZO
Arthroscope HRX
Nephroscope Set PPE
Resectoscope FJL
Resectoscope, Working Element FDC
Needle, Hypodermic, Single Lumen FMI
Syringe, Ent KCP
Ureteroscope And Accessories, Flexible/Rigid FGB
Syringe, Piston FMF
Syringe, Irrigating (Non Dental) KYZ
Dislodger, Stone, Basket, Ureteral, Metal FFL
Electrosurgical, Cutting & Coagulation & Accessories GEI
Accessories, Arthroscopic NBH
Evacuator, Gastro-Urology KQT
Irrigator, Powered Nasal KMA
Camera, Cine, Endoscopic, Without Audio FWL
Lithotriptor, Biliary Mechanical LQC
Accessories, Catheter, G-U KNY
Adaptor, Holder, Syringe IQG
Dispenser, Liquid Medication KYX
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
Otoscope ERA
Laryngoscope, Rigid CCW

Proprietary Names

FSM Bariatric Laparoscope Inflow Cannula Adapter Resection Instruments Laparoscope FAJ XION Laparoscopes HSW Laparosopes & Accessories Endoscope med reusable Fine-Ject Video Ureteroscope Soft-Ject Norm-Ject HSW Arthroscope 5MM 30° BARIATRIC LAPAROSCOPE, AC HD 10MM 0 DEGREES BARIATRIC IR LAPARSCOPE, AC 10MM 45° BARIATRIC LAPAROSCOPE, AC HD 5MM 30 DEGREES BARIATRIC IR LAPARSCOPE, AC 10MM 45° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM 10MM 0° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM 10MM 30° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM HD 5MM 0 DEGREE BARIATRIC IR LAPARASCOPE, AC 10MM 0° BARIATRIC LAPAROSCOPE, AC HD 5MM 45° BARIATRIC LAPAROSCOPE, AC HD 10MM 30 DEGREES BARIATRIC IR LAPARSCOPE, AC HD 5MM 45 DEGREES BARIATRIC IR LAPARSCOPE, AC HD 10MM 45 DEGREES BARIATRIC IR LAPARSCOPE, AC 10MM 30° BARIATRIC LAPAROSCOPE, AC HD 5MM 0° BARIATRIC LAPAROSCOPE, AC Nasopharyngoscope (flexible / rigid) Laparoscope, general and plastic surgery EOB XION Sinuscppes HSW Nasopharyngoscope & Accessories HSW Hysteroscope & Accessories Sheat HD 2.7MM X 70° ARTHROSCOPE SPEEDLOCK A/C HD 4MM X 70° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.3MM X 30 DEG, C-,MOUNT, REVERSE CANT, A/C IDEAL EYES PRECISION HD, 4MM, 30 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK 2.7MM 70 DEG AUTOCLAVABLE ARTHROSCOPE HD 2.3MM X 0° ARTHROSCOPE J-LOCK A/C 4MM 70° AUTOCLAVABLE HIP ARTHROSCOPE 4MM X 70° LONG ARTHROSCOPE SPEEDLOCK A/C HD 2.3MM X 30 DEGREE REVERSE CANT ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 2.3MM X 70 DEG, C-,MOUNT, A/C HD 2.7MM X 30° STUBBY ARTHROSCOPE J-LOCK A/C 2.7MM 0° C-MOUNT, ARTHROSCOPE HD 70 DEG., ARTHROSCOPE, 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C HD 2.7MM X 70° STUBBY ARTHROSCOPE J-LOCK A/C 4MM 30° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT 1.9MM X 30º C-MOUNT, A/C 4MM 0DEG C-MOUNT 2.7MM X 30° STUBBY AUTOCLAVABLE STUBBY SCOPE REVERSE CANT HD 1.9MM X 30 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 2.7MM 0° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT HD 2.3MM X 30° REVERSE CANT ARTHROSCOPE J-LOCK A/C HD 4MM X 0° ARTHROSCOPE SPEEDLOCK A/C IDEAL EYES 30° ARTHROSCOPE, 2.9 X 200 MM, EYEPIECE, SPEED-LOCK, AUTOCLAVABLE (SPA EYEPIECE SCOPE) HD 2.3MM X 70 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C HD 4MM X 70 DEG LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C HD 2.3MM X 30° ARTHROSCOPE J-LOCK A/C 2.9MM IDEAL EYES PRECISION HD AUTOCLAVABLE 200MM C-MOUNT ARTHROSCOPE - 30 DEG. WITH MODIFIED SPEEDLOCK HD 2.7MM X 0 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.3MM X 0 DEG, C-,MOUNT, A/C HD 30 DEG., 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C 4MM X 30° LONG ARTHROSCOPE SPEEDLOCK A/C 2.3MM X 30 DEG, A/C 2.7MM 30° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT HD 4MM X 0° ARTHROSCOPE, SPEEDLOCK, C-MOUNT HD 2.7MM X 30 DEGREE REVERSE CANT STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C HD 2.3MM X 70° ARTHROSCOPE J-LOCK A/C HD 2.3MM X 30 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 4MM 0° C-MOUNT STYLE A ARTHROSCOPE 4MM 70° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5 CM 4MM 70° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT HD 2.7MM X 0° STUBBY ARTHROSCOPE J-LOCK A/C 4MM A/C ARTHROSCOPE 4MM 0° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM HD 2.7MM X 70 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C IDEAL EYES PRECISION HD, 4MM, 70 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK 4MM X 0° LONG ARTHROSCOPE SPEEDLOCK A/C 4MM 30° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM PKG, 1.9MM TMJ, AUTOCLAVABLE 2.7MM 30°C-MOUNT, ARTHROSCOPE HD 4MM X 30° ARTHROSCOPE SPEEDLOCK A/C 4MM 30° AUTOCLAVABLE HIP ARTHROSCOPE HD 4MM X 30° REVERSE CANT LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C HD 4MM X 30° LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.7MM 70° A/C STUBBY ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT HD 30 DEG, ARTHROSCOPE, 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C, REVERSE CANT 2.7MM STUBBY SCOPE AUTOCLAVABLE HD 4MM X 30° REVERSE CANT ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C HD 1.9MM X 30° ARTHROSCOPE J-LOCK A/C HD 1.9MM X 0° ARTHROSCOPE J-LOCK A/C 2.7MM 30 DEG AUTOCLAVABLE ARTHROSCOPE HD 2.7MM X 30° ARTHROSCOPE SPEEDLOCK A/C 2.7MM 30° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT IDEAL EYES PRECISION HD, 4MM, 30 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, REVERSE CANT, SPEEDLOCK 4MM 70° C-MOUNT STYLE A ARTHROSCOPE HD 4MM X 30° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 4MM AUTOCLAVABLE ARTHROSCOPE 2.3MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK,C-MOUNT 2.7MM X 0 DEG, C-MOUNT, A/C 2.7MM X 70DEG STUBBY, A/C 2.7MM 0 DEG AUTOCLAVABLE ARTHROSCOPE HD 2.3MM X 0 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C IDEAL EYES PRECISION HD, 4MM, 0 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK HD 4MM X 45° ARTHROSCOPE, SPEEDLOCK, A/C 2.7MM 0° C-MOUNT, STUBBY 2.7MM 30° C-MOUNT, STUBBY 1.9MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK, C-MOUNT HD 2.7MM X 0° ARTHROSCOPE SPEEDLOCK A/C 4MM 30° C-MOUNT STYLE A ARTHROSCOPE HD 2.7MM X 30 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.3MM X 0 DEG, A/C HD 2.7MM X 70 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 4MM 0° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT HD 1.9 X 0 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 4MM 30° AUTOCLAVABLE REVERSE CANT ARTHROSCOPE, C-MOUNT HD 4MM X 70° ARTHROSCOPES, SPEEDLOCK, A/C 2.7MM X 30 DEG, C-MOUNT, A/C 2.3MM X 30 DEG, C-,MOUNT, A/C HD 4MM X 30° REVERSE CANT ARTHROSCOPE SPEEDLOCK A/C HD 2.7MM X 0 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C HD 2.7MM X 30 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C XION Hysteroscopes 4.4MM HIP OBTURATOR CANNULATED BLUNT TIP OBTURATOR FOR 2.9MM CANNULA 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR CANNULA, 2.8MM ONE FIXED STOPCOCK 2.3MM AUTOCLAVABLE PENCIL TIP OBTURATOR WITH SPEED-LOCK 3.2MM CANNULA WITH 2 FIXED STOPCOCKS TROCAR FOR 2.9MM CANNULA TROCAR FOR 2.8MM CANNULA CANNULA, 3.2MM ONE FIXED STOPCOCK BLUNT TIP OBTURATOR FOR 3.2 CANNULA CANNULA, 3.2MM TWO ROTATING STOPCOCKS PENCIL TIP OBTURATOR FOR 2.8MM J-LOCK CANNULA 3.2MM CANNULA WITH 1 ROTATING STOPCOCK 2.8MM CANNULA WITH 1 ROTATING STOPCOCK 1.9MM OBTURATOR 5.8MM HIPSCOPE CANNULA, 2 ROTATING STOPCOCKS 2.7MM OBTURATOR TROCAR FOR 3.2 CANNULA CANNULA, 2.8MM TWO FIXED STOPCOCKS 2.7MM SPEEDLOCK PENCIL TIP OBTURATOR 2.7MM TROCAR CANNULA, 3.2MM ONE ROTATING STOPCOCK 3.2MM SPEEDLOCK PENCIL TIP OBTURATOR BLUNT TIP OBTURATOR FOR 2.8MM CANNULA PENCIL TIP OBTURATOR FOR 3.2MM CANNULA 4MM, 30 HIP ARTHOSCOPE (HIPSCOPE) 2.8MM TWO ROTATING STOPCOCKS CANNULA, 4MM ONE FIXED STOPCOCK PENCIL TIP OBTURATOR FOR 2.8MM CANNULA 2.9MM AUTOCLAVABLE CANNULA, 1 ROTATING STOPCOCK W/SPEEDLOCK PENCIL TIP OBTURATOR FOR 4MM CANNULA 1.9MM TROCAR TROCAR FOR 4MM CANNULA 2.9MM CANNULA WITH 1 ROTATING STOPCOCK CANNULA, 3.2MM TWO FIXED STOPCOCKS 2.3MM AUTOCLAVABLE TROCAR FOR 2.9MM CANNULA WITH SPEED-LOCK TROCAR FOR 2.8MM J-LOCK CANNULA 3.2MM CANNULA WITH 2 ROTATING STOPCOCKS CANNULA, 2.8MM ONE ROTATING STOPCOCK 2.3MM OBTURATOR 4.4MM HIP TROCAR CANNULATED 4MM CANNULA WITH 2 FIXED STOPCOCKS 3.2MM CANNULA WITH 1 FIXED STOPCOCK PENCIL TIP OBTURATOR FOR 2.9MM CANNULA 2.3MM TROCAR 2.8MM CANNULA WITH 2 ROTATING STOPCOCKS 4MM CANNULA WITH 1 ROTATING STOPCOCK BLUNT TIP OBTURATOR FOR 4MM CANNULA 2.3MM AUTOCLAVABLE BLUNT TIP OBTURATOR WITH SPEED-LOCK 2.8MM CANNULA WITH 1 FIXED STOPCOCK 4MM CANNULA WITH 2 ROTATING STOPCOCKS WORKING ELEMENT, 22/24FR RESECTOSCOPE SHEATH, 2.9MM DIAGNOSTIC INNER SIDE FIRE LASER OUTER SHTH SHEATH, 2.9MM OPERATIVE INNER ELLIK EVACUATOR 27/28FR RESECTOSCOPE STANDARD OBTURATOR HYSTEROSCOPE, 2.9MM 0DEG 25FR VISUAL URETHROTOME OUTER SHEATH COLD KNIFE, STRAIGHT SHEATH, 22/24FR RESECTOSCOPE INNER 23FR CYSTO VISUAL OBTURATOR 21FR VISUAL URETHROTOME OPTICAL BRIDGE ELLIK ADAPTER CYSTO SHEATH HTA ADAPTER, 2.9MM HYSTEROSCOPE 21FR URETHROTOME STANDARD OBTURATOR 25FR CYSTO STANDARD OBTURATOR 19FR CYSTO VISUAL OBTURATOR HYSTEROSCOPE, 2.9MM 30DEG 17FR CYSTO STANDARD OBTURATOR HTA SCOPE BRIDGE HYSTEROSCOPE, 4MM 30DEG AUTOCLAVABLE SHEATH, 22/24FR RESECTOSCOPE OUTER OBTURATOR, 4MM OPERATIVE 4MM CYSTOSCOPE, KS SERIES 0DEG SHEATH, 2.9MM DIAGNOSTIC OUTER 24/26FR RESECTOSCOPE VISUAL OBTURATOR PORT SEAL 21FR CYSTOSCOPE SHEATH 27FR STANDARD FLOW RESECTOSCOPE SHEATH SHEATH, 4MM DIAGNOSTIC INNER 27FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE SHEATH, 4MM OPERATIVE INNER COLD KNIFE, HOOK COLD KNIFE, LOOP RIGID OPTICAL STONE CRUSHING FORCEP 30° CYSTOSCOPE, 4MM 30 DEG WITH GREEN LIGHT FILTER AUTOCLAVABLE 23FR CYSTO STANDARD OBTURATOR 4MM HYSTERSCOPE OPERATIVE SHEATH (7MM DIAMETER) 25FR CYSTO VISUAL OBTURATOR WORKING ELEMENT- ACTIVE (BAUMRUCKER) HYSTEROSCOPE, 4MM 0DEG AUTOCLAVABLE BLADDER SYRINGE ADAPTER, OUTER SHEATH CYSTOSCOPE, 4MM 30 DEG AUTOCLAVABLE 19FR CYSTOSCOPE SHEATH OBTURATOR, 2.9MM OPERATIVE 21FR CYSTO STANDARD OBTURATOR 4MM CYSTOSCOPE, KS SERIES 30DEG RIGID OPTICAL BIOPSY FORCEP 0°, 12° SINGLE HORN BRIDGE BLADDER SYRINGE ADAPTER CYSTO SHEATH RIGID OPTICAL STENT REMOVAL FORCEP 30° 24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH 23FR CYSTOSCOPE SHEATH ALBARRAN BRIDGE, SINGLE HORN RIGID OPTICAL FORCEP ADAPTER OUTER SHEATH HYSTEROSCOPE, 4MM 12DEG AUTOCLAVABLE SHEATH, 4MM DIAGNOSTIC OUTER ELLIK ADAPTER INNER SHEATH 17FR CYSTOSCOPE SHEATH 21FR URETHROTOME VISUAL OBTURATOR 4MM CYSTOSCOPE, KS SERIES 70DEG SIDE FIRE LASER INNR SHTH 4MM CYSTOSCOPE, KS SERIES 12DEG 4MM CANNULA WITH 1 FIXED STOPCOCK 24FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER OBTURATOR, 2.9MM DIAGNOSTIC RIGID OPTICAL BIOPSY FORCEP 30° STONE CRUSHING FORCEP ADAPTER, OUTER SHEATH WORKING ELEMENT- PASSIVE (IGLESIAS) RIGID OPTICAL BIOPSY FORCEP 70° 17FR CYSTO VISUAL OBTURATOR DOUBLE HORN BRIDGE CYSTOSCOPE, 4MM 0 DEG AUTOCLAVABLE 25FR BALLOON CATHETER SHEATH 2.7MM HYSTERSCOPE OPERATIVE SHEATH (6MM DIAMETER) BLADDER SYRINGE ADAPTER, INNER SHEATH HYSTEROSCOPE, 2.9MM 12DEG 27/28FR RESECTOSCOPE VISUAL OBTURATOR 27/28FR CONTINUOUS FLOW INNER/OUTER SHEATH 19FR CYSTO STANDARD OBTURATOR 21FR CYSTO VISUAL OBTURATOR ELLIK ADAPTER OUTER SHEATH SHEATH, 4MM OPERATIVE OUTER URETHRAL DILATOR SET, CURVED (8FR-30FR) SWEEP GUIDE SIDE FIRE LASER SHEATH SHEATH, 2.9MM OPERATIVE OUTER OBTURATOR FOR 2.7MM DIAGNOSTIC HYSTEROSCOPE SHEATH EVALUATION BRIDGE REUSABLE STOPCOCK 2.8MM CANNULA WITH 2 FIXED STOPCOCKS COLD KNIFE, SERRATED 24/26FR RESECTOSCOPE TIMBERLAKE OBTURATOR 4MM HYSTERSCOPE DIAGNOSTIC SHEATH (6MM DIAMETER) VISUAL OBTURATOR, LASER CYSTOSCOPE RIGID OPTICAL FORCEP ADAPTER INNER SHEATH 24/26FR RESECTOSCOPE STANDARD OBTURATOR 27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR LASER BRIDGE (FOR USE WITH STRAIGHT FIRE LASER) URETHRAL DILATOR SET, STRAIGHT (8FR-30FR) RIGID OPTICAL GRASPING FORCEP 0°, 12° OBTURATOR, 4MM DIAGNOSTIC 24FR STANDARD FLOW RESECTOSCOPE SHEATH COLD KNIFE, HALF MOON CYSTOSCOPE, 4MM 12 DEG AUTOCLAVABLE ALBARRAN BRIDGE, DOUBLE HORN STANDARD OBTURATOR, 22/24FR RESECTOSCOPE 21FR VISUAL URETHROTOME SHEATH 25FR CYSTOSCOPE SHEATH Laparoscopes GASTROENTEROLOGY-UROLOGY Devices HIH SYRINGE HOLDER XION Otoscope 10MM 90° OPERATING LAPAROSCOPE 10MM 0° OPERATIVE LAPAROSCOPE WITH 45° EYEPIECE 11MM 90° OPERATING LAPAROSCOPE HSW Laryngoscope Henke Sass Wolf of America Arthroscope 5MM 30° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE HD 5MM 30 DEGREES IR LAPARSCOPE, AC 5MM 45° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE 5MM 30° AUTOCLAVABLE LAPAROSCOPE 5MM 30° LAPAROSCOPE, AC 5MM 0° LAPAROSCOPE, AC HD 10MM 0 DEGREES IR LAPARSCOPE, AC 10MM 45° AUTOCLAVABLE LAPAROSCOPE HD 2.9MM 30° AC PEDIATRIC LAPAROSCOPE HD 10MM 45 DEGREES IR LAPARSCOPE, AC 5MM 45° AUTOCLAVABLE LAPAROSCOPE HD 10MM 30 DEGREES IR LAPARSCOPE, AC 10MM 30° AUTOCLAVABLE LAPAROSCOPE HD 2.9MM 0° AC PEDIATRIC LAPAROSCOPE 2.7MM 0° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM HD 5MM 45 DEGREES IR LAPARSCOPE, AC 10MM 0° AUTOCLAVABLE LAPAROSCOPE 5MM 45° LAPAROSCOPE, AC 10MM 30° LAPAROSCOPE, AC HD 5MM 0 DEGREES IR LAPARSCOPE, AC 2.7MM 30° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM 5MM 0° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE 5MM 0° AUTOCLAVABLE LAPAROSCOPE 10MM 0° LAPAROSCOPE, AC 10MM 45° LAPAROSCOPE, AC

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device