ARROW - Manual Needle Set - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Manual Needle Set

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More Product Details

Catalog Number

9094

Brand Name

ARROW

Version/Model Number

IPN055711

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"

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

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

4ba8f359-62aa-480a-9bea-86af694d4a7c

Public Version Date

March 07, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2020

Additional Identifiers

Package DI Number

20801902158233

Quantity per Package

6

Contains DI Package

10801902158236

Package Discontinue Date

March 04, 2022

Package Status

Not in Commercial Distribution

Package Type

Box

"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