LEUKOSTRIP 4X38MM CTN 50 - Wound closure strips - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Wound closure strips

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More Product Details

Catalog Number

66002876

Brand Name

LEUKOSTRIP 4X38MM CTN 50

Version/Model Number

66002876

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

-

Product Code Details

Product Code

MZR

Product Code Name

Topical Approximation System

Device Record Status

Public Device Record Key

f1dcddc0-67fe-4de5-b24a-4af3d0091d13

Public Version Date

July 08, 2020

Public Version Number

2

DI Record Publish Date

April 09, 2020

Additional Identifiers

Package DI Number

05000223448950

Quantity per Package

50

Contains DI Package

05000223448943

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