ARROW - 21 Ga. x 2-3/4" (7 cm) Echogenic Needle - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: 21 Ga. x 2-3/4" (7 cm) Echogenic Needle

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More Product Details

Catalog Number

PN-00217-E

Brand Name

ARROW

Version/Model Number

IPN033334

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K071998,K071998,K071998

Product Code Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

3f49c6cc-a556-4bd5-b410-4b9d89207397

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

20801902100911

Quantity per Package

25

Contains DI Package

00801902100917

Package Discontinue Date

-

Package Status

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