Identity
- Trade Name
- TGS FDA UDI
- Generic Name
- ENT headrest FDA UDI
- Device Name
- Universal Headrest Adapter C FDA UDI
- Model / Reference
- 8000-010-011 FDA UDI
- Description
- Universal Headrest Adapter C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850002250275 FDA UDI
- 510(k) Number
- K193502 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- ENT headrest FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENT headrest
Tgs by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT headrest.
- GYRUS ACMI — Gyrus Acmi, Inc. · Class II
- Neuro Adapter, (EU) — P AND G ENGINEERING INC · Class I
- GYRUS ACMI — Gyrus Acmi, Inc. · Class I
- GYRUS ACMI — Gyrus Acmi, Inc. · Class II
- Narrow Head Rest — P AND G ENGINEERING INC · Class I
- GYRUS ACMI, INC — Gyrus Acmi, Inc. · Class II
- TGS — Stryker Corp. · Class II
- TGS — Stryker Corp. · Class II
Cleared under the same submission
K193502 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI 8cd76b95-db29-4518-a9a5-ece5df8d580c 34 fields · synced May 30, 2026