Catalog Number

-

Brand Name

Infusion Safety Products, Inc.

Version/Model Number

ISP1975

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2020

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

K170881,K170881

Product Code

PTI

Product Code Name

Non-Coring (Huber) Needle

Public Device Record Key

98a09cbc-fcd9-497c-a26b-e97ab080881b

Public Version Date

February 26, 2020

Public Version Number

3

DI Record Publish Date

July 20, 2018

Package DI Number

28566730080027

Quantity per Package

25

Contains DI Package

08566730080023

Package Discontinue Date

February 21, 2020

Package Status

Not in Commercial Distribution

Package Type

-