Identity
- Trade Name
- BOLT KIT PTO 2L FDA UDI
- Generic Name
- Intracerebral catheter cranial-fixation kit FDA UDI
- Model / Reference
- 096076-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057834032109 FDA UDI
- FDA Product Code
- GWM FDA UDI
- GMDN Term
- Intracerebral catheter cranial-fixation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intracerebral catheter cranial-fixation kit
Bolt Kit Pto 2l by Raumedic Ag — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral catheter cranial-fixation kit.
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- Hummingbird® Cranial Access Kit — Irras USA
- CODMAN® — Integra LifeSciences Production Corporation · Class II
- QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit — HEMEDEX, INC · Class II
- Hummingbird® Cranial Access Kit — Irras USA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Raumedic Ag
Sources (1)
- FDA UDI 668eb450-1444-4fd8-9526-cd2f8c6f8bd7 33 fields · synced May 30, 2026