FDA Registration
Active
🇩🇪 Germany
55102 INSTRUMENT ADAPTER CLAMP STARLINK SIZE M
Reg #: 3033536255
·
FEI: 3033536255
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DHF PRAEZISIONSMECHANIK GMBH
- Registration Number
- 3033536255
- FEI Number
- 3033536255
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Oberrainer Feld 41
- City
- Tuntenhausen Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K183605
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 | 2025-01-28 |
Proprietary Names
55102 INSTRUMENT ADAPTER CLAMP STARLINK SIZE M
41801 INSTRUMENT TRACKING ARRAY STARLINK SIZE L
55103 INSTRUMENT ADAPTER CLAMP STARLINK SIZE L
52410A PATIENT REFERENCE ARRAY T-GEOMETRY X-PRESS
55830-29 INSTRUMENT TRACKING ARRAY S&T (SIZE L)
55104 INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL
55013 INSTRUMENT ADAPTER STARLINK ANGLED 45°
52411A PATIENT REFERENCE ARRAY Y-GEOMETRY X-PRESS
55101 INSTRUMENT ADAPTER CLAMP STARLINK SIZE S
52429 BONE FIXATOR 2-PIN X-PRESS
41802 INSTRUMENT TRACKING ARRAY STARLINK SIZE XL
41799 INSTRUMENT TRACKING ARRAY STARLINK SIZE ML
41798 INSTRUMENT TRACKING ARRAY STARLINK SIZE M
55016 INSTRUMENT ADAPTER STARLINK EXTENSION 50 MM
19142-06 RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)