Catalog Number

CATCH12

Brand Name

ReliaCatch

Version/Model Number

CATCH12

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

K163102,K163102,K163102

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

3b069f1d-3767-4498-a233-13017d87685e

Public Version Date

April 01, 2020

Public Version Number

5

DI Record Publish Date

July 14, 2017

Package DI Number

20884521704050

Quantity per Package

5

Contains DI Package

10884521704053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK