FDA UDI In Commercial Distribution 🇺🇸 United States

Super-X

DI: 00811114030926 · Model: SPRX500L · Unisafe Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
Super-X
Primary DI
00811114030926
Version / Model
SPRX500L
Company Name
Unisafe Inc.
Labeler DUNS
080171627
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2022-09-16
Public Version
2
Public Version Date
2023-06-05
Public Version Status
Update
Public Device Record Key
de426071-f299-49fa-9bdb-5d45322c5b68

Device Description

Powder-Free Latex Examination Gloves

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
Yes
Not Made with NRL
No
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LYY Latex Patient Examination Glove

GMDN Terms

Code Name
47172 Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

Identifiers

Type ID
Package 00811114030964
Primary 00811114030926
Unit of Use 10811114030923