Identity
- Trade Name
- Cover Gown FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- COVER GOWN 100%C UNBLEACHED L W/Tie Closures at Neck and Self Waist Ties Raglan Long Sleeves w/Natural Poly Cuffs FDA UDI
- Model / Reference
- 74103400 FDA UDI
- Description
- COVER GOWN 100%C UNBLEACHED L W/Tie Closures at Neck and Self Waist Ties Raglan Long Sleeves w/Natural Poly Cuffs FDA UDI
Identifiers
- Catalog Number
- 74103400 FDA UDI
- Primary DI / UDI-DI
- 00634916194173 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation gown, reusable FDA UDI
Classification
- Device Class
- Class I 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Cover Gown by Standard Textile Co., Inc. — Class I — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI 436a29ca-1403-49b8-8a4e-3e062d382841 36 fields · synced May 30, 2026