Identity
- Trade Name
- MICROTEK FDA UDI
- Generic Name
- X-ray system cover FDA UDI
- Device Name
- UNIVERSAL CASSETTE DRAPE (36/EA) 40 X 20, 1-EACH FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- UNIVERSAL CASSETTE DRAPE (36/EA) 40 X 20, 1-EACH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748426063635 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- X-ray system cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: X-ray system cover
Microtek by Microtek Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as X-ray system cover.
- Sterimed — Sterimed, Inc. · Class II
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- Sterimed — Sterimed, Inc. · Class II
- Sterimed — Sterimed, Inc. · Class II
- Sterimed — Sterimed, Inc. · Class II
- Sterimed — Sterimed, Inc. · Class II
- Sterimed — Sterimed, Inc. · Class II
- Sterimed — Sterimed, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Microtek Medical LLC
Sources (1)
- FDA UDI bc756bb3-6486-4516-a668-bb84e711e0aa 35 fields · synced Jun 8, 2026