FDA UDI In Commercial Distribution 🇺🇸 United States

HEPRO.US Nitrile Standard Class Series 400 Medium

DI: 00850578007877 · Model: BX - 400 Nitrile Medium · HEPRO.US INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100

Basic Information

Brand Name
HEPRO.US Nitrile Standard Class Series 400 Medium
Primary DI
00850578007877
Version / Model
BX - 400 Nitrile Medium
Company Name
HEPRO.US INC.
Labeler DUNS
080061451
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
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
81424534-f4d5-4bf1-9b8a-f71e82ec03f9

Device Description

HEPRO.US Nitrile Standard Class Series 400 Disposable Nitrile Gloves Series 400, Ambidextrous, Color Blue, Size Medium 1 Box 100pcs

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 00850578007877
Unit of Use 85057800787701