Catalog Number

343345

Brand Name

ASNIS

Version/Model Number

343345

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K213199,K220319

Product Code

HWC

Product Code Name

Screw, fixation, bone

Public Device Record Key

5f1b9e37-c267-4036-8d44-7591b2b98acf

Public Version Date

August 26, 2022

Public Version Number

2

DI Record Publish Date

June 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-