Identity
- Trade Name
- Stanguard Drape FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- SM UNIV DRAPE StanGuard 20X20 - B S W/3-1/2" FEN (SR 11657) FDA UDI
- Model / Reference
- 22626028 FDA UDI
- Description
- SM UNIV DRAPE StanGuard 20X20 - B S W/3-1/2" FEN (SR 11657) FDA UDI
Identifiers
- Catalog Number
- 22626028 FDA UDI
- Primary DI / UDI-DI
- 00634916343151 FDA UDI
- FDA Product Code
- PUI 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
Stanguard 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 1f6aaf11-5cfa-4757-9bde-8e00b0f405a4 36 fields · synced Jun 6, 2026