Identity
- Trade Name
- Encompass FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- VALUECARE ISO GOWN, XL, 100EA TS VALUECARE ISO GOWN, OH APRON, THUMBLOOP, BLUE PE PLASTIC FDA UDI
- Model / Reference
- VA550-25 FDA UDI
- Description
- VALUECARE ISO GOWN, XL, 100EA TS VALUECARE ISO GOWN, OH APRON, THUMBLOOP, BLUE PE PLASTIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00612899045484 FDA UDI
- FDA Product Code
- QPC FDA UDI
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical gown, single-use
Encompass by Encompass Group, L.L.C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Encompass Group, L.L.C.
Sources (1)
- FDA UDI d424164a-9133-44f4-8679-8c13a643b9e5 34 fields · synced Jun 8, 2026