Identity
- Trade Name
- PatientStyle FDA UDI
- Generic Name
- Patient gown, reusable FDA UDI
- Device Name
- Infant sheet printed new born. "Hatched" FDA UDI
- Model / Reference
- 410NB FDA UDI
- Description
- Infant sheet printed new born. "Hatched" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850011216071 FDA UDI
- FDA Product Code
- FME FDA UDI
- GMDN Term
- Patient gown, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6265 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PatientStyle by Patientstyle Medical Llc — 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 |
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Manufacturer
- Manufacturer
- Patientstyle Medical Llc
Sources (1)
- FDA UDI 39a35f87-efc8-40d2-aede-ff080b0604e3 34 fields · synced May 30, 2026