Catalog Number

M002000196270

Brand Name

Hemashield

Version/Model Number

M002000196270

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K955349

Product Code

DXZ

Product Code Name

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Public Device Record Key

f37b26d3-6648-4300-b961-2e2566c493c0

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

November 11, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-