Catalog Number

-

Brand Name

MaXcess

Version/Model Number

1564865

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042034

Product Code

FST

Product Code Name

LIGHT, SURGICAL, FIBEROPTIC

Public Device Record Key

0ab57d75-3a24-4a09-a8b3-51f78522ab56

Public Version Date

July 23, 2019

Public Version Number

1

DI Record Publish Date

July 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-