Identity
- Trade Name
- MAMMOGRAM JACKET FDA UDI
- Generic Name
- Patient gown, reusable FDA UDI
- Device Name
- MAMMOGRAM JACKET NOVA PINK OSFA FRONT CLSR W/2 METAL SNAPS FDA UDI
- Model / Reference
- 74F69081 FDA UDI
- Description
- MAMMOGRAM JACKET NOVA PINK OSFA FRONT CLSR W/2 METAL SNAPS FDA UDI
Identifiers
- Catalog Number
- 74F69081 FDA UDI
- Primary DI / UDI-DI
- 00634916009026 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
- 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
Category: Patient gown, reusable
Mammogram Jacket by Standard Textile Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient gown, reusable.
- Encompass — Encompass Group, L.L.C. · Class I
- Encompass — Encompass Group, L.L.C. · Class I
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class I
- Encompass — Encompass Group, L.L.C. · Class I
- Encompass — Encompass Group, L.L.C. · Class I
- DMI — DMS HOLDINGS, INC., · Class I
- Encompass — Encompass Group, L.L.C. · Class I
- Encompass — Encompass Group, L.L.C. · Class I
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 85488e0e-9911-440f-b178-7330e47ed13a 35 fields · synced May 31, 2026