Identity
- Trade Name
- Skull Pins FDA UDI
- Generic Name
- Cervical spine immobilization head ring rod FDA UDI
- Device Name
- Stainless Steel Skull Pin FDA UDI
- Model / Reference
- SP-001 FDA UDI
- Description
- Stainless Steel Skull Pin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331011364 FDA UDI
- 510(k) Number
- K163322 FDA UDI
- FDA Product Code
- HBL FDA UDI
- GMDN Term
- Cervical spine immobilization head ring rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4460 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Cervical spine immobilization head ring rod
Skull Pins by Tz Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cervical spine immobilization head ring rod.
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- V. Mueller — STERIS CORPORATION · Class II
- V. Mueller — STERIS CORPORATION · Class II
- V. Mueller — STERIS CORPORATION · Class II
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
- Tz Medical, Inc.
Sources (1)
- FDA UDI 1f12a85a-efec-45c8-83b4-e40c326ea1d1 34 fields · synced May 30, 2026