Catalog Number

FS+162530BC

Brand Name

NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE

Version/Model Number

16GX1" HC-30W

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

a2ae3e86-847b-4f38-9c47-b5d66987d63e

Public Version Date

December 20, 2018

Public Version Number

3

DI Record Publish Date

April 20, 2016

Package DI Number

40383790000121

Quantity per Package

10

Contains DI Package

10383790000120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case