Identity
- Trade Name
- Medline-Microtek FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- Patient Drape, Koslin TMJ Arthroscopy Drape, 196 cm x 141 cm (77 in x 55.5 in) FDA UDI
- Model / Reference
- Patient Drapes FDA UDI
- Description
- Patient Drape, Koslin TMJ Arthroscopy Drape, 196 cm x 141 cm (77 in x 55.5 in) FDA UDI
Identifiers
- Catalog Number
- 3982 FDA UDI
- Primary DI / UDI-DI
- 00748426142279 FDA UDI
- FDA Product Code
- PUI FDA UDI
- GMDN Term
- Patient surgical drape, single-use 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
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
Ethylene Oxide FDA UDI
Category: Patient surgical drape, single-use
Medline-Microtek by Microtek Medical LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Microtek Medical LLC
Sources (2)
- FDA UDI 70081e6d-da80-40bb-aa03-8607543c4d3d 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026