Catalog Number

10469

Brand Name

ACE-FISCHER®BAYONET POINT WIRE

Version/Model Number

10469

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K083789,K112218,K895079,K895079,K112218,K083789

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

bd04dc85-a68d-4cfc-b160-5ec747c041a7

Public Version Date

November 23, 2021

Public Version Number

5

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-