Uniseal BIO-NIT - Nitrile Biodegradable Powder Free Textured Blue - Uniseal

Duns Number:782209340

Device Description: Nitrile Biodegradable Powder Free Textured Blue Exam Gloves, Non- Sterile, Chemo and Fent Nitrile Biodegradable Powder Free Textured Blue Exam Gloves, Non- Sterile, Chemo and Fentanyl Tested, size XXL

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More Product Details

Catalog Number

-

Brand Name

Uniseal BIO-NIT

Version/Model Number

422-0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

e7f27ea7-da93-4673-82f7-d58c36218574

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Additional Identifiers

Package DI Number

30744514042200

Quantity per Package

10

Contains DI Package

20744514042203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"UNISEAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1