Catalog Number

SAC-00522

Brand Name

ARROW

Version/Model Number

IPN030312

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"

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

K093050,K093050

Product Code

DQX

Product Code Name

Wire, guide, catheter

Public Device Record Key

2aeb8d12-a283-4a5d-8a0a-8647c4d03c01

Public Version Date

January 12, 2022

Public Version Number

8

DI Record Publish Date

September 16, 2016

Package DI Number

30801902102752

Quantity per Package

10

Contains DI Package

00801902102751

Package Discontinue Date

January 10, 2022

Package Status

Not in Commercial Distribution

Package Type

Case