Catalog Number

1202-01

Brand Name

Capture™

Version/Model Number

1202-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

387eca29-7fbf-47fd-ad54-3ed31b72f70d

Public Version Date

July 22, 2021

Public Version Number

7

DI Record Publish Date

September 17, 2016

Package DI Number

M7831202011

Quantity per Package

25

Contains DI Package

M7831202010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case