FDA UDI In Commercial Distribution 🇺🇸 United States

Tronex International, Inc.

DI: 10097604861028 · Model: 8610-UNI · TRONEX INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000

Basic Information

Brand Name
Tronex International, Inc.
Primary DI
10097604861028
Version / Model
8610-UNI
Company Name
TRONEX INTERNATIONAL, INC.
Labeler DUNS
615425519
Distribution Status
In Commercial Distribution
Device Count in Pkg
1000
Record Status
Published
Publish Date
2022-10-28
Public Version
1
Public Version Date
2022-11-07
Public Version Status
New
Public Device Record Key
2e4cb7dc-8cf4-404f-bc57-937e124481f3

Device Description

Glove, Exam, Vinyl, Synthetic + Memory, Powder-Free, Latex-Free, Natural, 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
LYZ Vinyl Patient Examination Glove

GMDN Terms

Code Name
47176 Vinyl examination/treatment glove, non-powdered

Identifiers

Type ID
Unit of Use 00097604861021
Primary 10097604861028