JMS SYSLOC A.V.FISTULA NEEDLE SET - SYSLOC AVF 15GX11/4" BE 30CM W/CLAMP - JMS SINGAPORE PTE LTD

Duns Number:595159278

Device Description: SYSLOC AVF 15GX11/4" BE 30CM W/CLAMP

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More Product Details

Catalog Number

-

Brand Name

JMS SYSLOC A.V.FISTULA NEEDLE SET

Version/Model Number

824-1502-33

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

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Device Record Status

Public Device Record Key

7d547468-2b81-4c96-b1d4-6e4b7dcd58b3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

58888483005401

Quantity per Package

300

Contains DI Package

08888483005406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"JMS SINGAPORE PTE LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 53