Catalog Number

-

Brand Name

Hemasorb 2.0 gram

Version/Model Number

OS-201NS

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

K043260,K043260

Product Code

MTJ

Product Code Name

Wax,Bone

Public Device Record Key

96d4fa64-1ac1-4eef-951c-51bfc87f2ece

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 16, 2016

Package DI Number

10850391007037

Quantity per Package

2

Contains DI Package

00850391007030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OS-401 Box