Catalog Number

62501

Brand Name

Biolon

Version/Model Number

version 1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 15, 2020

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

P960011,P960011,P960011,P960011,P960011,P960011,P960011,P960011

Product Code

LZP

Product Code Name

AID, SURGICAL, VISCOELASTIC

Public Device Record Key

2749f09b-5e7c-439c-986a-e3a4ed6a8fed

Public Version Date

April 11, 2022

Public Version Number

4

DI Record Publish Date

May 17, 2018

Package DI Number

01369918000007

Quantity per Package

185

Contains DI Package

00369918000008

Package Discontinue Date

September 15, 2020

Package Status

Not in Commercial Distribution

Package Type

case