Catalog Number

62501

Brand Name

Biolon

Version/Model Number

version 1

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"

-

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

Product Code

LZP

Product Code Name

AID, SURGICAL, VISCOELASTIC

Public Device Record Key

96541455-637c-416e-b750-b0949f2fbf6a

Public Version Date

June 15, 2022

Public Version Number

1

DI Record Publish Date

June 07, 2022

Package DI Number

15060156070380

Quantity per Package

185

Contains DI Package

15060156070373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case