Catalog Number

905213

Brand Name

ComposiTCP

Version/Model Number

ComposiTCP 30 round head

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2015

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

K122228

Product Code

MAI

Product Code Name

Fastener, Fixation, Biodegradable, Soft Tissue

Public Device Record Key

cc4fa495-f29d-44ef-ad20-93e5ebd4f5f9

Public Version Date

July 14, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-