Identity
- Trade Name
- Tronex International, Inc. FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Gown, Chemotherapy Rated, Isolation, Multilayer Spunbond, Knitted Cuffs, Fluid Impervious, Latex-Free, Blue, Extra-Large FDA UDI
- Model / Reference
- 6333CHEMO35 FDA UDI
- Description
- Gown, Chemotherapy Rated, Isolation, Multilayer Spunbond, Knitted Cuffs, Fluid Impervious, Latex-Free, Blue, Extra-Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10097604633342 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation 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: Isolation gown, single-use
Tronex International, Inc. by Tronex International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isolation gown, single-use.
- VIVIT Supply — Vivit Supply LLC · Class I
- customized — Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Class I
- CONVERTORS — Cardinal Health 200, LLC · Class I
- Industrial Gown - White — ULINE, INC. · Class I
- Protexter — ICP MEDICAL, LLC · Class I
- 3D DENTAL-ESSENTIALS — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- VIVIT Supply — Vivit Supply LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · 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
- Tronex International, Inc.
Sources (1)
- FDA UDI ee1f57b3-90b2-41b9-beb4-0f0014a2bd3e 33 fields · synced Jun 8, 2026