FDA UDI
In Commercial Distribution
🇺🇸 United States
Tronex International, Inc.
DI: 10097604601129
·
Model: 6011C25
·
TRONEX INTERNATIONAL, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
75
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Basic Information
- Brand Name
- Tronex International, Inc.
- Primary DI
- 10097604601129
- Version / Model
- 6011C25
- Company Name
- TRONEX INTERNATIONAL, INC.
- Labeler DUNS
- 615425519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2022-10-28
- Public Version
- 2
- Public Version Date
- 2025-04-30
- Public Version Status
- Update
- Public Device Record Key
- 7bc2a855-77e5-4f8c-b5b2-b2d55fba2783
Device Description
Gown, Isolation, Cast Polyethylene, Over-the-Head Thumb-Hook, Fluid Impervious, Latex-Free, Blue, Unisize
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FYE | Dress, Surgical | General, Plastic Surgery | 878.4040 | 1 |
| OEA | Non-Surgical Isolation Gown | General, Plastic Surgery | 878.4040 | 1 |
| FME | Gown, Examination | General Hospital | 880.6265 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35492 | Isolation gown, single-use | A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00097604601122 | GS1 | ||||
| Primary | 10097604601129 | GS1 |