ARROW - Continuous Nerve Block Needle - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: Continuous Nerve Block Needle

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More Product Details

Catalog Number

AB-00090

Brand Name

ARROW

Version/Model Number

IPN040002

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

K121403,K121403,K121403

Product Code Details

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Device Record Status

Public Device Record Key

a01d8cce-770f-45c9-8353-1d8f6f925ef1

Public Version Date

January 08, 2021

Public Version Number

7

DI Record Publish Date

December 22, 2016

Additional Identifiers

Package DI Number

20801902028376

Quantity per Package

10

Contains DI Package

40801902028370

Package Discontinue Date

February 24, 2020

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