Catalog Number

-

Brand Name

Hemasorb 2.0 gram with Spatula

Version/Model Number

OS-201

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

27ebefbc-ad21-472d-aff5-ca45bd705af2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

00850391007153

Quantity per Package

1

Contains DI Package

00850391007023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-