FDA UDI In Commercial Distribution 🇺🇸 United States

HEPRO.US Disposable Nitrile Gloves Class 400 XL

DI: 00850578007969 · Model: CT - 400 Nitrile XL · HEPRO.US INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000

Basic Information

Brand Name
HEPRO.US Disposable Nitrile Gloves Class 400 XL
Primary DI
00850578007969
Version / Model
CT - 400 Nitrile XL
Company Name
HEPRO.US INC.
Labeler DUNS
080061451
Distribution Status
In Commercial Distribution
Device Count in Pkg
1000
Record Status
Published
Publish Date
2017-06-21
Public Version
3
Public Version Date
2020-06-19
Public Version Status
Update
Public Device Record Key
ae126785-7a6d-409e-a9ee-a50d9ac8d0fd

Device Description

Hepro.us Disposable Nitrile Gloves Class 400 Hepro.us Nitrile Disposable Gloves Deluxe Class 400, Color Blue, Non-Powdered, Textured, Size X-Large, 1Case of 10 Boxes = 1,000 pcs

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
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
Yes

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LZA Polymer Patient Examination Glove

GMDN Terms

Code Name
56286 Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Identifiers

Type ID
Primary 00850578007969
Unit of Use 85057800796902