ENDOTRIG - Hook Blade - Stryker Trauma SA

Duns Number:481999654

Device Description: Hook Blade

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More Product Details

Catalog Number

1052-6

Brand Name

ENDOTRIG

Version/Model Number

1052-6

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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)

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

NBH

Product Code Name

ACCESSORIES,ARTHROSCOPIC

Device Record Status

Public Device Record Key

440f7706-ea0f-4d00-9deb-f135f80a1720

Public Version Date

September 02, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

37613327364102

Quantity per Package

6

Contains DI Package

07613327364101

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

pack

"STRYKER TRAUMA SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2606
2 A medical device with a moderate to high risk that requires special controls. 9953
3 A medical device with high risk that requires premarket approval 186