Catalog Number

70-1031-CAP0027

Brand Name

Capture

Version/Model Number

70-1031-CAP0027

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"

-

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

-

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

28e3bea2-c6c2-4911-be35-e6f1176bdbf3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 21, 2017

Package DI Number

D745701031CAP00141

Quantity per Package

20

Contains DI Package

D745701031CAP00270

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack