Catalog Number

680132/A

Brand Name

Exacta™

Version/Model Number

10884450389994

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

36a3165c-36ca-4e21-a7cd-9d4b1a4166b7

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

September 04, 2019

Package DI Number

20884450389991

Quantity per Package

10

Contains DI Package

10884450389994

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-