SKIN-PREP Wipes - Protective dressing wipes - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Protective dressing wipes

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More Product Details

Catalog Number

59420425

Brand Name

SKIN-PREP Wipes

Version/Model Number

59420425

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)

Yes

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

ff9da294-e345-4476-b476-5dc7e1aad86c

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 04, 2020

Additional Identifiers

Package DI Number

00040565120317

Quantity per Package

50

Contains DI Package

00040565120300

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