Catalog Number

100163

Brand Name

ACE-FISCHER®PIN HOLDER BOLT

Version/Model Number

10016-3

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

K112218,K801594

Product Code

HXK

Product Code Name

HOLDER, NEEDLE; ORTHOPEDIC

Public Device Record Key

a22b318e-62ff-47e9-9a5e-7180a3a3da6b

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

-