Identity
- Trade Name
- HammerTube System FDA UDI
- Generic Name
- Bone trephine, reusable FDA UDI
- Device Name
- Trephine Ø2.75mm FDA UDI
- Model / Reference
- P40-910-2750 FDA UDI
- Description
- Trephine Ø2.75mm FDA UDI
Identifiers
- Catalog Number
- P40-910-2750 FDA UDI
- Primary DI / UDI-DI
- 00889795039408 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Bone trephine, 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Bone trephine, reusable
HammerTube System by Paragon 28 — 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
- Paragon 28
Sources (1)
- FDA UDI ae4cb97b-4693-41b1-8c77-01b2325d5f67 34 fields · synced Jun 8, 2026