OPSITE FLEXIGRID USA 6X7CM-CARTON OF 100 - Transparent Dressing - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Transparent Dressing

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More Product Details

Catalog Number

66024628

Brand Name

OPSITE FLEXIGRID USA 6X7CM-CARTON OF 100

Version/Model Number

66024628

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

e49867fe-48a7-4b07-87fa-3967af86d1b9

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

June 04, 2021

Additional Identifiers

Package DI Number

05000223438500

Quantity per Package

100

Contains DI Package

05000223415402

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