Identity
- Trade Name
- Ortho Surgical Drape FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- ORTHO FUSION ROLLCOVER - 22.5X20.5 W/13" VELCRO STRIPS FDA UDI
- Model / Reference
- 95869400 FDA UDI
- Description
- ORTHO FUSION ROLLCOVER - 22.5X20.5 W/13" VELCRO STRIPS FDA UDI
Identifiers
- Catalog Number
- 95869400 FDA UDI
- Primary DI / UDI-DI
- 00634916009262 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Patient surgical drape, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ortho Surgical Drape by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI 7037f0ab-4439-459e-b1f4-6a26d1a5704f 36 fields · synced May 30, 2026