No-Sting SKIN-PREP Wipes - No-sting protective wipe - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: No-sting protective wipe

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More Product Details

Catalog Number

59420600

Brand Name

No-Sting SKIN-PREP Wipes

Version/Model Number

59420600

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

NEC

Product Code Name

Bandage, Liquid, Skin Protectant

Device Record Status

Public Device Record Key

ff923865-76fe-4f8c-851c-67400c676b19

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

September 04, 2020

Additional Identifiers

Package DI Number

00040565116730

Quantity per Package

50

Contains DI Package

00040565116747

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