Catalog Number

FS+183230BC-G

Brand Name

NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE

Version/Model Number

18G X 1-1/4"

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

FIE

Product Code Name

Needle, fistula

Public Device Record Key

5cf503f6-f498-40af-bb63-22572a7d3291

Public Version Date

September 26, 2019

Public Version Number

1

DI Record Publish Date

September 18, 2019

Package DI Number

40383790007519

Quantity per Package

10

Contains DI Package

10383790007518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case