FDA Registration
Active
🇩🇪 Germany
DHF PRAEZISIONSMECHANIK GMBH
Reg #: 3033536255
·
FEI: 3033536255
·
Expires 2026
Products
4
Proprietary Names
56
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- DHF PRAEZISIONSMECHANIK GMBH
- Registration Number
- 3033536255
- FEI Number
- 3033536255
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Oberrainer Feld 41
- City
- Tuntenhausen Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- DHF Praezisionsmechanik GmbH
- Operator Number
- 10091494
- Address
- Oberrainer Feld 41
- City
- Tuntenhausen
- State
- Bavaria
- Postal Code
- 83104
- Country
- DE
- Correspondent
- Bernhard Fischbacher
US Agent
- Business Name
- IUVO Consulting, LLC
- Contact Name
- Rhonda Alexander
- Address
- 1820 Perla Dr
- City
- Virginia Beach
- State
- VA
- ZIP
- 23456
- Country
- US
- [email protected]
- Phone
- 757 5824337
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-10-09 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-28 |
| Screwdriver, Skullplate | GXL | Class 1 | Neurology | No | 2025-01-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2025-01-28 |
Proprietary Names
HIP7
52411A PATIENT REFERENCE ARRAY Y-GEOMETRY X-PRESS
52410A PATIENT REFERENCE ARRAY T-GEOMETRY X-PRESS
55104 INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL
55101 INSTRUMENT ADAPTER CLAMP STARLINK SIZE S
52429 BONE FIXATOR 2-PIN X-PRESS
55102 INSTRUMENT ADAPTER CLAMP STARLINK SIZE M
41798 INSTRUMENT TRACKING ARRAY STARLINK SIZE M
41802 INSTRUMENT TRACKING ARRAY STARLINK SIZE XL
55013 INSTRUMENT ADAPTER STARLINK ANGLED 45°
55103 INSTRUMENT ADAPTER CLAMP STARLINK SIZE L
41799 INSTRUMENT TRACKING ARRAY STARLINK SIZE ML
41801 INSTRUMENT TRACKING ARRAY STARLINK SIZE L
55016 INSTRUMENT ADAPTER STARLINK EXTENSION 50 MM
55830-29 INSTRUMENT TRACKING ARRAY S&T (SIZE L)
19142-06 RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT
41767-19A MICROSCOPE TRACKING ARRAY
41767-55B MICROSCOPE ADAPTER FOR TRACKING ARRAY (ZEISS)
52424 DOUBLE OPEN-END WRENCH (10 X 14 MM)
41860-35C ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S)
52122A Skull Reference Array
55791A HANDLE FOR MULTIPLE TIP POINTER
41860-40A ULTRASOUND NAVIGATION ADAPTER (BK N13C5)
52129B Skull Reference Base
41860-35B ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S)
41860-43 ULTRASOUND NAVIGATION ADAPTER (BK X18L5S)
55105 INSTRUMENT ADAPTER CLAMP STARLINK FOR RECTANGULAR INSTRUMENTS
55950-70G VARIOGUIDE HARDWARE (VERSION G)
55950-40B VARIOGUIDE ARRAY
41734 Pat. Ref. Attachment for Skull Clamp
41725 Pat. Ref. Array for Skull Clamp
41860-40 ULTRASOUND NAVIGATION ADAPTER (BK N13C5)
56302 Cirq Robotic Tracking Array Spine 10
56302A CIRQ ROBOTIC TRACKING ARRAY 10
51839-03 Drill Guide Array
51839-32 Drill Guide Tube (3.2 mm)
51839-01 Drill Guide Depth Control ( 0-60 mm)
51839-93 Drill Guide Trocar Insert 2 mm
51839-26 Drill Guide Tube (2.6 mm)
51839-96 Drill Guide Trocar Insert 3.2 mm
51839-20 Drill Guide Tube (2 mm)
51839-95 Drill Guide Trocar Insert 2.6 mm
51839-24 Drill Guide Tube (2.4 mm)
51839-94 Drill Guide Trocar Insert 2.4 mm
51839-97 Drill Guide Trocar Insert 4.5 mm
51839-02 Drill Guide Depth Control (60-100 mm)
51839-45 Drill Guide Tube (4.5 mm)
51839 Drill Guide Handle
55955-10 VARIOGUIDE JOINT ARM KIT
55955-41 VARIOGUIDE ARRAY 4-MARKER
55955-30 VARIOGUIDE JOINT ARRAY HOLDER
56402 Cirq Robotic Tracking Array Cranial 7.5
55956-21 VARIOGUIDE DISC SET 4 MM TO 8 MM
55956-31 VARIOGUIDE DISC SET CRANIAL DRILL KIT
55955-20 VARIOGUIDE JOINT DISC
55956-11 VARIOGUIDE DISC SET 1.8 MM TO 4 MM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)