Catalog Number

-

Brand Name

Surgidac

Version/Model Number

170043

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

K934738,K934738

Product Code

OCW

Product Code Name

Endoscopic tissue approximation device

Public Device Record Key

90a157b4-b525-4e95-90a3-48feb2149642

Public Version Date

July 26, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884521128972

Quantity per Package

3

Contains DI Package

20884521128979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE