Identity
- Trade Name
- NOVO Health Services, LLC FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- 5 LP DECON GWN, SM N/S FDA UDI
- Model / Reference
- 8515 FDA UDI
- Description
- 5 LP DECON GWN, SM N/S FDA UDI
Identifiers
- Catalog Number
- 8515 FDA UDI
- Primary DI / UDI-DI
- 00812564032034 FDA UDI
- FDA Product Code
- FYC FDA UDI
- GMDN Term
- Isolation 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NOVO Health Services, LLC by Novo Health Services, Llc — 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
- Novo Health Services, Llc
Sources (1)
- FDA UDI c0f52427-f042-4220-85bf-71669bcb8f52 36 fields · synced May 30, 2026