Identity
- Trade Name
- Strong Manufacturers FDA UDI
- Generic Name
- Professional examination gown, single-use FDA UDI
- Device Name
- Yellow SMS Disposable Cover Gown, Universal Size, Full Back, Neck Ties and Elastic Cuffs, Case of 50 each FDA UDI
- Model / Reference
- 5201 FDA UDI
- Description
- Yellow SMS Disposable Cover Gown, Universal Size, Full Back, Neck Ties and Elastic Cuffs, Case of 50 each FDA UDI
Identifiers
- Catalog Number
- 5201 FDA UDI
- Primary DI / UDI-DI
- 00853927007757 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Professional examination gown, single-use FDA UDI
Classification
- Device Class
- Class I 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Professional examination gown, single-use
Strong Manufacturers by Strong Medical Partners LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Strong Medical Partners LLC
Sources (1)
- FDA UDI 11de3af7-920f-43f0-b510-aa6a2577a0d3 36 fields · synced May 30, 2026