Catalog Number

GCAF-001

Brand Name

Coda®

Version/Model Number

GCAF-001

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

-

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

K001486,K001486

Product Code

MQG

Product Code Name

ACCESSORY, ASSISTED REPRODUCTION

Public Device Record Key

c13f8bb7-c8d1-4c0f-8655-1fa62a28c6d7

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

00815965021577

Quantity per Package

2

Contains DI Package

00815965021195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

2-pack, GCAF-002