FDA Registration
Active
🇩🇪 Germany
51839-26 Drill Guide Tube (2.6 mm)
Reg #: 3033536255
·
FEI: 3033536255
·
Expires 2025
Products
1
Proprietary Names
14
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
- K240701
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
51839-26 Drill Guide Tube (2.6 mm)
51839-97 Drill Guide Trocar Insert 4.5 mm
51839-96 Drill Guide Trocar Insert 3.2 mm
51839 Drill Guide Handle
51839-03 Drill Guide Array
51839-24 Drill Guide Tube (2.4 mm)
51839-01 Drill Guide Depth Control ( 0-60 mm)
51839-93 Drill Guide Trocar Insert 2 mm
51839-45 Drill Guide Tube (4.5 mm)
51839-32 Drill Guide Tube (3.2 mm)
51839-95 Drill Guide Trocar Insert 2.6 mm
51839-94 Drill Guide Trocar Insert 2.4 mm
51839-20 Drill Guide Tube (2 mm)
51839-02 Drill Guide Depth Control (60-100 mm)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)