N/A - Intracardiac Catheter Introducer Kit - Synaptic Medical, Ltd.

Duns Number:421256891

Device Description: Intracardiac Catheter Introducer Kit

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

S0806332L0

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"

-

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

d7e6a6c0-16b6-4a82-8fbb-5e63135b3717

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

May 17, 2018

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