FDA Registration
Active
🇩🇪 Germany
Cirq Robotic Instrument Holder Cranial
Reg #: 8043933
·
FEI: 3002619595
·
Expires 2025
Products
1
Proprietary Names
28
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BRAINLAB AG
- Registration Number
- 8043933
- FEI Number
- 3002619595
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Olof-Palme-Strasse 9
- City
- Munich Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K223864
Owner / Operator
- Firm Name
- Brainlab AG
- Operator Number
- 9004547
- Address
- Olof-Palme-Strasse 9
- City
- Munich
- State
- Bavaria
- Postal Code
- 81829
- Country
- DE
US Agent
- Business Name
- BRAINLAB, INC.
- Contact Name
- Paul Neil
- Address
- 5 Westbrook Corporate Ctr Ste 1000
- City
- WESTCHESTER
- State
- IL
- ZIP
- 60154
- Country
- US
- [email protected]
- Phone
- 708 4091343
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2023-09-11 |
Proprietary Names
Cirq Robotic Instrument Holder Cranial
VARIOGUIDE JOINT ARM KIT
Alignment Reduction Tube Cranial 2.5/4
Alignment Guide Tube Cranial 4/7.5
VARIOGUIDE DISC SET 4 MM TO 8 MM
DRILL BIT CRANIAL 3.4/3.8
VARIOGUIDE JOINT DISC
DRILL BIT CRANIAL 2.1/4
Alignment System Cranial
Alignment Software Cranial
Cirq Alignment Software Cranial Biopsy
Cirq Alignment Software Cranial sEEG
Varioguide Alignment Software Cranial
DRILL BIT CRANIAL 2.4/4
Cirq Robotic Disposable Kinematic Unit
VARIOGUIDE DISC SET CRANIAL DRILL KIT
DRILL BIT CRANIAL 2.1/2.5
Alignment Guide Tube Cranial 3.8/7.5
DRILL BIT CRANIAL 2.4/2.5
DRILL DEPTH STOP CRANIAL 4
VARIOGUIDE JOINT ARRAY HOLDER
DRAPELINK REF ADAPTER AUTO-REG IMRI
AUTO-REG MATRIX IMRI
VARIOGUIDE DISC SET 1.8 MM TO 4 MM
DRILL DEPTH STOP CRANIAL 2.5
Alignment Guide Tube Cranial 2.5/7.5
VARIOGUIDE ARRAY 4-MARKER
Cirq Robotic Tracking Array Cranial 7.5
Establishment Types
Manufacture Medical Device