Catalog Number

CAT02969

Brand Name

NanoTack

Version/Model Number

CAT02969

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K131769

Product Code

MBI

Product Code Name

FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Public Device Record Key

3133744b-3bc4-4acf-9be6-3437c6bc15e2

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

July 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-