Catalog Number

4001

Brand Name

SurgiFish

Version/Model Number

4001 Pouch

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"

Yes

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

-

Product Code

GCZ

Product Code Name

Retainer, Surgical

Public Device Record Key

ad0ced93-f395-4456-99dd-c8e3346f39c0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 15, 2017

Package DI Number

00854373007063

Quantity per Package

10

Contains DI Package

00854373007094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box