Identity
- Trade Name
- GYRUS ACMI FDA UDI
- Generic Name
- Dry medical towel/wipe, single-use FDA UDI
- Device Name
- MICRO-INSTRUMENT WIPE 3.5" X 3.5" FDA UDI
- Model / Reference
- 230030 FDA UDI
- Description
- MICRO-INSTRUMENT WIPE 3.5" X 3.5" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925033580 FDA UDI
- FDA Product Code
- NAB FDA UDI
- GMDN Term
- Dry medical towel/wipe, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dry medical towel/wipe, single-use
Gyrus Acmi by Gyrus Acmi, Inc. — 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 8ef57807-2e0d-44bc-b7c8-6a436de8f733 33 fields · synced May 30, 2026