Sentus - BIOTRONIK SE & Co. KG

Duns Number:315620229

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

406082

Brand Name

Sentus

Version/Model Number

ProMRI OTW QP S-85/49

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

P070008,P070008

Product Code Details

Product Code

OJX

Product Code Name

Drug eluting permanent left ventricular (lv) pacemaker electrode

Device Record Status

Public Device Record Key

f6eba94a-fb98-4a65-b6a3-9f8cf442fcc9

Public Version Date

September 22, 2021

Public Version Number

5

DI Record Publish Date

May 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOTRONIK SE & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 97
3 A medical device with high risk that requires premarket approval 402