FDA UDI In Commercial Distribution 🇺🇸 United States

PrimaPro

DI: 00850022371370 · Model: 414-45 · PRIMARY PRODUCTS COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
PrimaPro
Primary DI
00850022371370
Version / Model
414-45
Company Name
PRIMARY PRODUCTS COMPANY
Labeler DUNS
089569581
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2020-09-09
Public Version
2
Public Version Date
2020-12-31
Public Version Status
Update
Public Device Record Key
7e8030ae-0a81-4962-a1e4-a2f5a89f73b2

Device Description

PrimaPro GentleGuard Vinyl Powder Free Examination Glove X-Large, 100 Gloves/Box, 10 Box/Case, 1,000 Gloves/Case, Ambidextrous, Beaded Cuff, Non-Sterile, Single Use

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
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
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
Package 10850022371377
Primary 00850022371370
Unit of Use 20850022371374