Catalog Number

-

Brand Name

Polysorb

Version/Model Number

273023

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 14, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K961578

Product Code

JDR

Product Code Name

STAPLE, FIXATION, BONE

Public Device Record Key

842daa55-3d30-45d8-891f-2e2b242023de

Public Version Date

February 11, 2022

Public Version Number

6

DI Record Publish Date

August 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-