WEREWOLF - WEREWOLF ENT - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: WEREWOLF ENT

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More Product Details

Catalog Number

72290144

Brand Name

WEREWOLF

Version/Model Number

72290144

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

-

Prescription Use (Rx)

Yes

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

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Device Record Status

Public Device Record Key

7a62d55b-3fe9-4cc2-863b-cd19f7f71b4c

Public Version Date

January 13, 2021

Public Version Number

2

DI Record Publish Date

January 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351