Catalog Number

-

Brand Name

SourceMark

Version/Model Number

CV1BL

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRC

Product Code Name

Instrument, Ent Manual Surgical

Public Device Record Key

2fe239f1-592d-4b81-8143-984889136481

Public Version Date

July 22, 2020

Public Version Number

1

DI Record Publish Date

July 14, 2020

Package DI Number

10813799003704

Quantity per Package

20

Contains DI Package

00813799003691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box