Catalog Number

01-0042RTR

Brand Name

ARROW

Version/Model Number

IPN922674

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

K180588,K180588,K180588

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

8f060202-eb91-43c5-b161-fc847a9a36aa

Public Version Date

January 28, 2022

Public Version Number

1

DI Record Publish Date

January 20, 2022

Package DI Number

40801902203210

Quantity per Package

5

Contains DI Package

50801902203217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case