Catalog Number

8054-8

Brand Name

NA

Version/Model Number

8054-8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 07, 2022

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

K901035,K901035

Product Code

FST

Product Code Name

LIGHT, SURGICAL, FIBEROPTIC

Public Device Record Key

cd7e189c-a413-4be2-97f7-d8626607446b

Public Version Date

June 08, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-