Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Sterilization container mat FDA UDI
- Device Name
- Rigid Container Sterilization 10x5x0.25 Silicone Blue CA/1 Not made with Natural Rubber Latex Medichoice FDA UDI
- Model / Reference
- 58278 FDA UDI
- Description
- Rigid Container Sterilization 10x5x0.25 Silicone Blue CA/1 Not made with Natural Rubber Latex Medichoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632436765 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Sterilization container mat FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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: Sterilization container mat
MediChoice by Owens & Minor Distribution, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
Cleared under the same submission
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K233578 also covers:
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
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
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI a60a5f43-0b4c-4fc3-b23d-152fd4b3d0b4 34 fields · synced Jun 6, 2026