Identity
- Trade Name
- PRIMED FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, XL. FDA UDI
- Model / Reference
- PM4-68394XL FDA UDI
- Description
- Overhead AAMI 4 Open Back Gown, Knit Cuff, Blue, XL. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842942017254 FDA UDI
- FDA Product Code
- FYA 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
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
No
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
Primed by priMED Medical Products Inc — 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
- priMED Medical Products Inc
Sources (1)
- FDA UDI 234bbd02-2312-4b48-bfee-bde83f32ba4b 34 fields · synced May 31, 2026