Catalog Number

US-8002LZV

Brand Name

U.S. IOL, Inc.

Version/Model Number

US-8002LZV

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

K140039,K140039

Product Code

GAM

Product Code Name

SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Public Device Record Key

c6e111f9-1fe9-4891-897c-5b7bfbb559ab

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 22, 2020

Package DI Number

00814106016113

Quantity per Package

12

Contains DI Package

00814106016106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 12