ARROW - EZ-IO(R) 45mm Needle Set - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: EZ-IO(R) 45mm Needle Set

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More Product Details

Catalog Number

9079-VC-005

Brand Name

ARROW

Version/Model Number

IPN917347

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

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

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

266a3624-3941-45e3-b3bd-72e4de58e1ea

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Additional Identifiers

Package DI Number

20801902170631

Quantity per Package

5

Contains DI Package

10801902170634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26