EXU-DRY ADULT BUTTOCK PKG 10 - Specialty Absorptive, wound dressing - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Specialty Absorptive, wound dressing

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More Product Details

Catalog Number

5999BP1

Brand Name

EXU-DRY ADULT BUTTOCK PKG 10

Version/Model Number

5999BP1

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Device Record Status

Public Device Record Key

bb83ca87-2735-45d5-a3c0-2dd5b6ab7fce

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

July 16, 2020

Additional Identifiers

Package DI Number

30040565118841

Quantity per Package

10

Contains DI Package

00040565118840

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