FDA UDI
In Commercial Distribution
🇺🇸 United States
Tronex International, Inc.
DI: 10097604555514
·
Model: 5555W
·
TRONEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
300
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Basic Information
- Brand Name
- Tronex International, Inc.
- Primary DI
- 10097604555514
- Version / Model
- 5555W
- Company Name
- TRONEX INTERNATIONAL, INC.
- Labeler DUNS
- 615425519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2025-07-28
- Public Version
- 1
- Public Version Date
- 2025-08-05
- Public Version Status
- New
- Public Device Record Key
- 75aa2228-910a-4868-8685-b19a62e72698
Device Description
Mask, Procedure, Spunbond, ASTM Level 2, MR Safe, Earloop, Fluid Resistant, White, 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
- No
- 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 |
|---|---|---|---|---|
| FXX | Mask, Surgical | General, Plastic Surgery | 878.4040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66199 | Surgical/medical face mask, non-antimicrobial, single-use | A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00097604555517 | GS1 | ||||
| Primary | 10097604555514 | GS1 |
Customer Contacts
- Phone
- 973-335-2888
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123787 | 000 |