NA - Electrophysiology Catheter - Synaptic Medical, Ltd.

Duns Number:421256891

Device Description: Electrophysiology Catheter

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More Product Details

Catalog Number

F6004005115FRT

Brand Name

NA

Version/Model Number

F6004005115FRT

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

DRF

Product Code Name

Catheter, Electrode Recording, Or Probe, Electrode Recording

Device Record Status

Public Device Record Key

380e9554-ebc8-4fd1-8d75-23d8e8674818

Public Version Date

March 29, 2018

Public Version Number

2

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