Catalog Number

AK-00376

Brand Name

ARROW

Version/Model Number

IPN010811

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K874063,K874063

Product Code

KDD

Product Code Name

KIT, SURGICAL INSTRUMENT, DISPOSABLE

Public Device Record Key

06a7ce4a-5a71-4900-b62a-da2cd09ace84

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

30801902004773

Quantity per Package

6

Contains DI Package

00801902004772

Package Discontinue Date

July 24, 2017

Package Status

Not in Commercial Distribution

Package Type

Case