Identity
- Trade Name
- Tronex International, Inc. FDA UDI
- Generic Name
- Professional examination gown, single-use FDA UDI
- Device Name
- Jacket, Lab, Multilayer, Knitted Collar, Knitted Cuffs, Fluid Resistant, Latex-Free, White, 3X-Large FDA UDI
- Model / Reference
- SMS54945W FDA UDI
- Description
- Jacket, Lab, Multilayer, Knitted Collar, Knitted Cuffs, Fluid Resistant, Latex-Free, White, 3X-Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10097604549452 FDA UDI
- FDA Product Code
- LYU 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
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
MR Safe FDA UDI
Category: Professional examination gown, single-use
Tronex International, Inc. by Tronex International, Inc. — 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
- Tronex International, Inc.
Sources (1)
- FDA UDI c6f3d1c6-8ed5-4505-b144-95cfdf2a8d41 34 fields · synced May 31, 2026