Identity
- Trade Name
- KOMET GUIDE PIN/SCREW FDA UDI
- Generic Name
- Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
- Model / Reference
- GP002.089.032.M4 FDA UDI
Identifiers
- Catalog Number
- GP002.089.032 STE FDA UDI
- Primary DI / UDI-DI
- 14053613164433 FDA UDI
- 510(k) Number
- K131264 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Category: Intraoperative orthopaedic bone pin/screw, single-use
Komet Guide Pin/Screw by Gebr. Brasseler GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Intraoperative orthopaedic bone pin/screw, single-use.
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Cleared under the same submission
K131264 also covers:
- GUIDE PIN SET — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- GUIDE PIN/SCREW — Gebr. Brasseler GmbH & Co. KG
- Guide Pin — Gebr. Brasseler GmbH & Co. KG
- Guide Pin & Guide Screw Kit — Gebr. Brasseler GmbH & Co. KG
- Guide Pin Set — Gebr. Brasseler GmbH & Co. KG
- Guide Screw — Gebr. Brasseler GmbH & Co. KG
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
- Gebr. Brasseler GmbH & Co. KG
Sources (1)
- FDA UDI 13f4ac96-0a1e-44d3-bd33-d166df8d5202 34 fields · synced May 30, 2026