Catalog Number

ITS-10-RS

Brand Name

Single Spike Infiltration Tubing - ReShape

Version/Model Number

ITS-10-RS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 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"

Yes

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

d31a5ce6-b30e-4abe-9cd9-ee372d7ec070

Public Version Date

July 01, 2020

Public Version Number

2

DI Record Publish Date

May 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-