FDA UDI In Commercial Distribution 🇺🇸 United States

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DI: 00810045480060 · Model: NTX0301 · Hemasource, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Select Choice
Primary DI
00810045480060
Version / Model
NTX0301
Company Name
Hemasource, Inc.
Labeler DUNS
009046405
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-08
Public Version
2
Public Version Date
2023-01-20
Public Version Status
Update
Public Device Record Key
d2d1a104-793c-4caf-ab29-77e86a765d53

Device Description

EXAM GLOVE NITRILE P-FREE SM SELECT CHOICE 2000/CSE

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
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
LZA Polymer Patient Examination Glove

GMDN Terms

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

Identifiers

Type ID
Primary 00810045480060
Package 00810045480220