Catalog Number

SAC-02318

Brand Name

ARROW

Version/Model Number

IPN030339

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

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

4b6766e0-d59c-4e0d-9d6b-b6564c0826ee

Public Version Date

January 14, 2022

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

30801902102844

Quantity per Package

10

Contains DI Package

00801902102843

Package Discontinue Date

January 12, 2022

Package Status

Not in Commercial Distribution

Package Type

Case