FDA UDI In Commercial Distribution 🇺🇸 United States

Criterion

DI: 10304040192020 · Model: 5705403 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
Criterion
Primary DI
10304040192020
Version / Model
5705403
Catalog Number
5705403
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2025-11-12
Public Version
1
Public Version Date
2025-11-20
Public Version Status
New
Public Device Record Key
d13be818-83f2-4400-bcd6-38190027dbfb

Device Description

Criterion CR Aqua Blue Glove Large

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LZA Polymer patient examination glove

GMDN Terms

Code Name
56288 Polychloroprene examination/treatment glove, non-powdered

Identifiers

Type ID
Unit of Use 00304040192023
Primary 10304040192020