NA - Steerable Intracardiac Catheter Introducer Kit - Synaptic Medical, Ltd.

Duns Number:421256891

Device Description: Steerable Intracardiac Catheter Introducer Kit

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


More Product Details

Catalog Number

S08574LS

Brand Name

NA

Version/Model Number

S08574LS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

5c18fa5b-d592-4661-bccb-03011d92f9e6

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

November 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNAPTIC MEDICAL, LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 35