Curity - AMD Antimicrobial Non-woven Sponges,4 Ply, 0.2% - Cardinal Health, Inc.

Duns Number:080935429

Device Description: AMD Antimicrobial Non-woven Sponges,4 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)

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More Product Details

Catalog Number

8047AMD

Brand Name

Curity

Version/Model Number

8047AMD

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"

-

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

K011941,K011941,K011941,K011941

Product Code Details

Product Code

EFQ

Product Code Name

GAUZE/SPONGE, INTERNAL

Device Record Status

Public Device Record Key

4118b185-1426-48bc-acab-4ee3215abaaa

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Additional Identifiers

Package DI Number

30884521138159

Quantity per Package

1600

Contains DI Package

10884521138155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17