Catalog Number

-

Brand Name

MaxG 4mm Adapter 5 pack

Version/Model Number

2520-0035

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

K142376,K142376

Product Code

GEX

Product Code Name

Powered laser surgical instrument

Public Device Record Key

a52a8db2-eb61-4f5a-8f1c-c240c93086cf

Public Version Date

September 14, 2018

Public Version Number

1

DI Record Publish Date

August 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-