Catalog Number

-

Brand Name

TAPES

Version/Model Number

TAPES

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

K211309,K211309,K211309,K211309

Product Code

OCW

Product Code Name

Endoscopic Tissue Approximation Device

Public Device Record Key

74cfbcc9-1961-46ea-b1be-3e26d7375414

Public Version Date

August 25, 2022

Public Version Number

2

DI Record Publish Date

July 19, 2022

Package DI Number

05425029282698

Quantity per Package

6

Contains DI Package

05425029282094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

secondary packaging