Catalog Number

INSC-P-7-230-S

Brand Name

Instinct

Version/Model Number

G58010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

PKL

Product Code Name

Hemostatic metal clip for the GI tract

Public Device Record Key

f02821be-22b0-43ba-8891-55803cd3d11c

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 25, 2020

Package DI Number

10827002580104

Quantity per Package

10

Contains DI Package

00827002580107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Each