MediChoice - Gauze Sponge Usp Type VII Sterile 2/Pack 4 Inch X - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Gauze Sponge Usp Type VII Sterile 2/Pack 4 Inch X 4 Inch 12-Ply 100% Cotton Single Use Onl Gauze Sponge Usp Type VII Sterile 2/Pack 4 Inch X 4 Inch 12-Ply 100% Cotton Single Use Only Not Made With Natural Rubber Latex MediChoice Non-Acute Only

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


More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

GZ74004

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Device Record Status

Public Device Record Key

8064ef93-9bc4-4144-9dde-4631ab943d50

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

September 21, 2020

Additional Identifiers

Package DI Number

20885632068529

Quantity per Package

24

Contains DI Package

30885632068526

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