Identity
- Trade Name
- Medical Action Industries FDA UDI
- Generic Name
- Urinary catheter holder FDA UDI
- Model / Reference
- 80391B FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10809160345108 FDA UDI
- FDA Product Code
- OHR FDA UDI
- GMDN Term
- Urinary catheter holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
Yes
FDA UDI
Combination Product
Yes
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: Urinary catheter holder
Medical Action Industries by Medical Action Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urinary catheter holder.
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- Catheter Stabilization Device — C. R. Bard, Inc. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
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
- Medical Action Industries Inc.
Sources (1)
- FDA UDI ad00a8da-30eb-4bc3-90a7-fa9728629373 33 fields · synced May 30, 2026