FDA UDI In Commercial Distribution 🇺🇸 United States

Blackwork

DI: 10850002097136 · Model: 1040 · Blackwork Worldwide LLC
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
Blackwork
Primary DI
10850002097136
Version / Model
1040
Company Name
Blackwork Worldwide LLC
Labeler DUNS
045085221
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2023-01-30
Public Version
2
Public Version Date
2023-05-03
Public Version Status
Update
Public Device Record Key
fa9ae87b-1717-4d8e-83ce-acf866d768a7

Device Description

Gloves, Exam, Chloroprene, Non-Sterile, Powder-Free, Textured, Black, L

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OPC Powder-Free Polychloroprene Patient Examination Glove
LZC Medical Glove, Specialty

GMDN Terms

Code Name
56288 Polychloroprene examination/treatment glove, non-powdered

Identifiers

Type ID
Package 20850002097133
Primary 10850002097136
Unit of Use 00850002097139