PiGalileo TKR - PLUS PIGALILEO TKR FEM CLAMP - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: PLUS PIGALILEO TKR FEM CLAMP PLIERS TKR

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

75009249

Brand Name

PiGalileo TKR

Version/Model Number

75009249

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

K061362

Product Code Details

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Device Record Status

Public Device Record Key

3e825a33-ac8b-44d7-b3fd-cf557744e277

Public Version Date

October 18, 2021

Public Version Number

3

DI Record Publish Date

February 13, 2017

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