Catalog Number

-

Brand Name

Captivator™ COLD

Version/Model Number

M00561100

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

-

Product Code

FGX

Product Code Name

SNARE, NON-ELECTRICAL

Public Device Record Key

3f7222e9-e4d1-4af9-b2e3-3e1b244b2d97

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

June 14, 2018

Package DI Number

08714729971269

Quantity per Package

10

Contains DI Package

08714729971252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-