Catalog Number

222220

Brand Name

TACIT

Version/Model Number

222220

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 28, 2021

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

K945203,K945203

Product Code

JDR

Product Code Name

STAPLE, FIXATION, BONE

Public Device Record Key

f3c5e2f4-b1a5-4e60-9455-fa8deba84aab

Public Version Date

January 28, 2021

Public Version Number

7

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-