Catalog Number

110026112

Brand Name

ComposiTCP™

Version/Model Number

Suture Anchor Punch Tap

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

K170868

Product Code

MAI

Product Code Name

Fastener, Fixation, Biodegradable, Soft Tissue

Public Device Record Key

9c6646cc-2196-4ed7-9235-3e430dbf2384

Public Version Date

July 16, 2019

Public Version Number

3

DI Record Publish Date

March 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-