Catalog Number

46.307

Brand Name

LAZIC

Version/Model Number

46.307

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

-

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

-

Product Code

GEG

Product Code Name

Elevator, Surgical, General & Plastic Surgery

Public Device Record Key

e63e2caa-fff9-4a78-9b1a-59babf340617

Public Version Date

August 13, 2020

Public Version Number

1

DI Record Publish Date

August 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-