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

Duns Number:007941230

Device Description: Glove Exam Procedure Nitrile 9.5-Inch Cuff Small Sterile Ambidextrous Singles Powder-Free Glove Exam Procedure Nitrile 9.5-Inch Cuff Small Sterile Ambidextrous Singles Powder-Free Textured Beaded Cuff Disposable Not Made With Natural Rubber Latex MediChoice

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

GLV5001S

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

8522d718-b3ac-43d5-8b42-64d49ab3bf2a

Public Version Date

October 23, 2020

Public Version Number

1

DI Record Publish Date

October 15, 2020

Additional Identifiers

Package DI Number

30885632111185

Quantity per Package

100

Contains DI Package

10885632111181

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