Catalog Number

9770357

Brand Name

Sherlock 3CG+

Version/Model Number

9770357

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

LJS

Product Code Name

Catheter, intravascular, therapeutic, long-term greater than 30 days

Public Device Record Key

bd6bdc2c-8418-4003-b296-a1479ab77a3a

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Package DI Number

20801741213278

Quantity per Package

4

Contains DI Package

10801741213271

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-