VARIAX - Bone Screw, T6 - Stryker Trauma SA

Duns Number:481999654

Device Description: Bone Screw, T6

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More Product Details

Catalog Number

663812S

Brand Name

VARIAX

Version/Model Number

663812S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K180500

Product Code Details

Product Code

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

423959b8-f6b6-41e7-80a3-c8ab18cdc563

Public Version Date

August 02, 2018

Public Version Number

1

DI Record Publish Date

July 02, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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