Catalog Number

FS+162530BCR

Brand Name

NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE

Version/Model Number

16GX1" HTC-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

c4542094-4697-4420-a1b9-52922cb598d3

Public Version Date

December 20, 2018

Public Version Number

3

DI Record Publish Date

April 20, 2016

Package DI Number

10383790000137

Quantity per Package

50

Contains DI Package

00383790000130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton