Identity
- Trade Name
- Coulmed FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Standard Sterile Surgical Gown, X-Large, AAMI 3 FDA UDI
- Model / Reference
- DI-5953-506 FDA UDI
- Description
- Standard Sterile Surgical Gown, X-Large, AAMI 3 FDA UDI
Identifiers
- Catalog Number
- DI-5953-506 FDA UDI
- Primary DI / UDI-DI
- 10810087350274 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Coulmed by Coulmed Products Group 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
- Coulmed Products Group Llc
Sources (1)
- FDA UDI 585039fd-e371-4bb5-b453-8eb01be7b661 35 fields · synced May 30, 2026