FDA Registration
Active
🇩🇪 Germany
41860-40 ULTRASOUND NAVIGATION ADAPTER (BK N13C5)
Reg #: 3033536255
·
FEI: 3033536255
·
Expires 2025
Products
1
Proprietary Names
23
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
- K192703
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 |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-01-28 |
Proprietary Names
41860-40 ULTRASOUND NAVIGATION ADAPTER (BK N13C5)
19142-06 RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT
55104 INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL
55950-70G VARIOGUIDE HARDWARE (VERSION G)
41860-35C ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S)
41860-35B ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S)
55013 INSTRUMENT ADAPTER STARLINK ANGLED 45°
52122A Skull Reference Array
41734 Pat. Ref. Attachment for Skull Clamp
41798 INSTRUMENT TRACKING ARRAY STARLINK SIZE M
41801 INSTRUMENT TRACKING ARRAY STARLINK SIZE L
41860-40A ULTRASOUND NAVIGATION ADAPTER (BK N13C5)
41802 INSTRUMENT TRACKING ARRAY STARLINK SIZE XL
55105 INSTRUMENT ADAPTER CLAMP STARLINK FOR RECTANGULAR INSTRUMENTS
52129B Skull Reference Base
55103 INSTRUMENT ADAPTER CLAMP STARLINK SIZE L
41799 INSTRUMENT TRACKING ARRAY STARLINK SIZE ML
55101 INSTRUMENT ADAPTER CLAMP STARLINK SIZE S
55791A HANDLE FOR MULTIPLE TIP POINTER
55950-40B VARIOGUIDE ARRAY
55102 INSTRUMENT ADAPTER CLAMP STARLINK SIZE M
41860-43 ULTRASOUND NAVIGATION ADAPTER (BK X18L5S)
41725 Pat. Ref. Array for Skull Clamp
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)