Catalog Number

-

Brand Name

Solvent Medical

Version/Model Number

649

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

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Public Device Record Key

8599a476-7a22-4489-bc25-04be0c7dcc2b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 02, 2016

Package DI Number

20862412000207

Quantity per Package

50

Contains DI Package

10862412000200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case