CUTICERIN 7.5X7.5CM CTN 50 - Impregnated Gauze Dressing - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Impregnated Gauze Dressing

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


More Product Details

Catalog Number

66045560

Brand Name

CUTICERIN 7.5X7.5CM CTN 50

Version/Model Number

66045560

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K842967,K842967,K842967

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

e9226f29-cf04-4afe-ab8a-3abef7c92f16

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Additional Identifiers

Package DI Number

05000223450168

Quantity per Package

50

Contains DI Package

05000223450151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"SMITH & NEPHEW MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 126
U Unclassified 1