MediChoice - Glove Exam Nitrile 9.5-Inch Cuff Medium - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Glove Exam Nitrile 9.5-Inch Cuff Medium Non-Sterile Ambidextrous Powder-Free Textured Bead Glove Exam Nitrile 9.5-Inch Cuff Medium Non-Sterile Ambidextrous Powder-Free Textured Beaded Cuff Disposable Cleared For Use With Some Chemotherapy Drugs Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

GLV5002

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)

-

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

3c30fe2a-ae83-46f7-a80a-9375ade88125

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 2020

Additional Identifiers

Package DI Number

50885632111196

Quantity per Package

10

Contains DI Package

30885632111192

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1