Catalog Number

CR1007

Brand Name

Hemorrhage Occluder Pin with Applicator

Version/Model Number

CR1007

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"

Yes

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

K890447,K890447

Product Code

GDW

Product Code Name

Staple, Implantable

Public Device Record Key

03b709cf-b3b0-4d9b-8454-bbfef1dce6d7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2015

Package DI Number

10868742000101

Quantity per Package

2

Contains DI Package

00868742000104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box