Identity
- Trade Name
- StanGuard Barrier Supreme Surgical Drape FDA UDI
- Generic Name
- Patient surgical drape, reusable FDA UDI
- Device Name
- MAYO COVER LGE STGUARD - 27X63 BARRIER SUPREME FDA UDI
- Model / Reference
- 22620922 FDA UDI
- Description
- MAYO COVER LGE STGUARD - 27X63 BARRIER SUPREME FDA UDI
Identifiers
- Catalog Number
- 22620922 FDA UDI
- Primary DI / UDI-DI
- 00634916001051 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 Barrier Supreme 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 c4cdc402-b770-4910-a1c6-cd0b4220eaac 36 fields · synced Jun 1, 2026