VISCOPASTE PB7 3""X10YD CTN 12 - Zinc Paste Bandage - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Zinc Paste Bandage

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More Product Details

Catalog Number

4956

Brand Name

VISCOPASTE PB7 3""X10YD CTN 12

Version/Model Number

4956

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

K863930,K863930,K863930

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

f779ce11-7911-44ee-920d-e4828bd51518

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

May 15, 2020

Additional Identifiers

Package DI Number

05000223415044

Quantity per Package

12

Contains DI Package

05000223415457

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