Catalog Number

700012060

Brand Name

Orbit®Inserter

Version/Model Number

700012060

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KZH

Product Code Name

INTRODUCER, SYRINGE NEEDLE

Public Device Record Key

0369d3aa-764a-4d6c-809f-129490aa0059

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 09, 2017

Package DI Number

07613117022235

Quantity per Package

10

Contains DI Package

07613117021979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHIPPER BOX