Identity
- Trade Name
- Perval Surgical Gown FDA UDI
- Generic Name
- Surgical gown, reusable FDA UDI
- Device Name
- OR GWN PERVAL PLUS CEIL 3XL - TT @ WST W/BCODE S/R 12374 FDA UDI
- Model / Reference
- 75665132 FDA UDI
- Description
- OR GWN PERVAL PLUS CEIL 3XL - TT @ WST W/BCODE S/R 12374 FDA UDI
Identifiers
- Catalog Number
- 75665132 FDA UDI
- Primary DI / UDI-DI
- 00634916049176 FDA UDI
- 510(k) Number
- K950504 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 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
No
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
Perval Surgical Gown 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 ce1aaaea-1958-433d-b471-e660c31fc194 37 fields · synced Jun 8, 2026