Identity
- Trade Name
- Gyrus ACMI FDA UDI
- Generic Name
- Hand-held endoscopic retractor, reusable FDA UDI
- Device Name
- GUTHRIE HOOK, SMALL, EBONY FDA UDI
- Model / Reference
- 231014 FDA UDI
- Description
- GUTHRIE HOOK, SMALL, EBONY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925018976 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Hand-held endoscopic retractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- Not 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
Gyrus ACMI by Gyrus Acmi, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 6a74befa-9762-4298-87d8-34ccac6b4a04 34 fields · synced May 30, 2026