Catalog Number

B1-020-99-1

Brand Name

Skytron Lite-Lok

Version/Model Number

B1-020-99-1

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"

Yes

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

-

Product Code

FTA

Product Code Name

Light, Surgical, Accessories

Public Device Record Key

5de41211-4eca-4ebb-8124-515decfcad7c

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Package DI Number

30748426118510

Quantity per Package

40

Contains DI Package

00748426118519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-