FDA UDI In Commercial Distribution 🇺🇸 United States

NEXT-GEN

DI: 00850043811503 · Model: 43-101L · Genesee Scientific Holdings, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
NEXT-GEN
Primary DI
00850043811503
Version / Model
43-101L
Catalog Number
43-101L
Company Name
Genesee Scientific Holdings, LLC
Labeler DUNS
943016071
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2022-08-18
Public Version
1
Public Version Date
2022-08-26
Public Version Status
New
Public Device Record Key
2e5ab270-6a65-4bb0-85bc-84cd6222e862

Device Description

E-GEN Powder-Free Latex Examination Gloves, Size L, 100

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Primary 00850043811503
Unit of Use 10850043811500
Package 00850043811510