Identity
- Trade Name
- Osteotec CBG Spike S FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- A spike has been included in the kit, this is to be inserted through the body of the tube saw and is used to centralize the saw when starting the cut. FDA UDI
- Model / Reference
- OST-CBG-16 FDA UDI
- Description
- A spike has been included in the kit, this is to be inserted through the body of the tube saw and is used to centralize the saw when starting the cut. FDA UDI
Identifiers
- Catalog Number
- OST-CBG-16 FDA UDI
- Primary DI / UDI-DI
- 05060183095700 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone awl, reusable
Osteotec CBG Spike S by Osteotec, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Osteotec, Ltd.
Sources (1)
- FDA UDI d99b0b43-bcf0-4780-acc8-4cbfe094be7c 34 fields · synced Jun 6, 2026