Identity
- Trade Name
- Armatec® FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- LEICA OHS/OH1 DRAPE W/RUBBERBANDS, 137 cm x 381 cm (54 in x 150 in) FDA UDI
- Model / Reference
- Equipment Drapes FDA UDI
- Description
- LEICA OHS/OH1 DRAPE W/RUBBERBANDS, 137 cm x 381 cm (54 in x 150 in) FDA UDI
Identifiers
- Catalog Number
- AR8033598R FDA UDI
- Primary DI / UDI-DI
- 00748426141630 FDA UDI
- FDA Product Code
- PUI FDA UDI
- GMDN Term
- Medical equipment/instrument 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: Medical equipment/instrument drape, single-use
Armatec® by Microtek Medical LLC — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Microtek Medical LLC
Sources (1)
- FDA UDI 91e32e14-2d19-4a67-a0ab-d17d73333ff2 34 fields · synced Jun 8, 2026