ANTIMICROBIAL GAUZE - Antimicrobial Gauze - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Antimicrobial Gauze

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More Product Details

Catalog Number

66801691

Brand Name

ANTIMICROBIAL GAUZE

Version/Model Number

66801691

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142979,K142979

Product Code Details

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Device Record Status

Public Device Record Key

e04179aa-7665-47fa-a0a1-8efc91b10a51

Public Version Date

August 24, 2021

Public Version Number

7

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

30040565127126

Quantity per Package

10

Contains DI Package

00040565127125

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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