Identity
- Trade Name
- GYRUS ACMI FDA UDI
- Generic Name
- ENT headrest FDA UDI
- Device Name
- SMALL DISPOSABLE "DONUT" HEAD REST NOTE: IF USING THIS PRODUCT IN STERILE FIELD, DRAPE APPROPIATELY (12/PK) FDA UDI
- Model / Reference
- 290135 FDA UDI
- Description
- SMALL DISPOSABLE "DONUT" HEAD REST NOTE: IF USING THIS PRODUCT IN STERILE FIELD, DRAPE APPROPIATELY (12/PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925037731 FDA UDI
- FDA Product Code
- EPW FDA UDI
- GMDN Term
- ENT headrest FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ENT headrest
Gyrus Acmi by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as ENT headrest.
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- Narrow Head Rest — P AND G ENGINEERING INC · Class I
- TGS — Stryker Corp. · Class II
- GYRUS ACMI — Gyrus Acmi, Inc. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 07e2ddbc-6355-4ce7-9d9f-5d5bb3c37fc9 34 fields · synced Jun 1, 2026