FDA Registration
Active
🇺🇸 United States
Stryker Sustainability Solutions - Chandler
Reg #: 3030153385
·
FEI: 3030153385
·
Expires 2026
Products
12
Proprietary Names
34
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- Stryker Sustainability Solutions - Chandler
- Registration Number
- 3030153385
- FEI Number
- 3030153385
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6635 W Frye Rd
- City
- Chandler
- State
- AZ
- ZIP
- 85226
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220481
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-05-27 |
| Oximeter, Reprocessed | NLF | Class 2 | Cardiovascular | No | 2022-04-11 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2017-02-23 |
| Single-Use Reprocessed Ultrasonic Surgical Instruments | NLQ | Class U | Unknown | No | 2017-02-23 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-08-07 |
| Laparoscope, General & Plastic Surgery, Reprocessed | NLM | Class 2 | Gastroenterology, Urology | No | 2020-08-07 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2025-08-20 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2007-06-20 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2020-10-05 |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | Class 2 | General, Plastic Surgery | No | 2022-05-27 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2010-02-05 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2010-12-06 |
Proprietary Names
Remanufactured LigaSure Exact Dissector, Without Nano-coating
Reprocessed Nellcor Pulse Oximeter Sensor
Reprocessed Harmonic ACE+7, 5mm Diameter Shears with Advanced Hemostasis
Reprocessed Endoscopic Trocars and Sleeves
Reprocessed HARMONIC ACE+ 7, 5 Mm Diameter Shears With Advanced Hemostasis
Reprocessed HARMONIC HAR1100 Shears
Reprocessed Harmonic ACE Shears without adaptive tissue technology
Reprocessed Masimo Pulse Oximeter Sensor
Reprocessed RD Set
Reprocessed Tourniquet Cuff
Reprocessed MyoSure XL Tissue Removal Device
Reprocessed MyoSure LITE Tissue Removal Device
Reprocessed MyoSure XL Tissue Removal Device for Fluent
Reprocessed MyoSure Tissue Removal Device
Reprocessed MyoSure REACH Tissue Removal Device
Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider
Remanufactured LigaSure Exact Dissector Without Nano-coating
Reprocessed Arthroscopic Cutters
LXMJ44S Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Without Nano-coating 5mm
LXMJ44L Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider Latching Handle, Without Nano-coating 5mm -
LXMJ23S Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider One-step Sealing, Without Nano-coating 5mm - 23cm
LXMJ23L Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider Latching Handle, Without Nano-coating 5mm - 23cm
LXMJ37L Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider Latching Handle, Without Nano-coating 5mm -
LXMJ37S Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Without Nano-coating 5mm
Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Dividers
Reprocessed Trocars and Stability Sleeves
Reprocessed Compression Sleeve
Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
Reprocessed HARMONIC 700 Shears
Reprocessed RD SET Pulse Oximeter Sensor
Reprocessed HARMONIC 1100 Shears
Reprocessed LigaSure Maryland Jaw Sealer/Divider
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Reprocessed Blunt Tip Laparoscopic Sealer/Divider
Establishment Types
Reprocess Single-Use Device
Remanufacture Medical Device