ARROW - UltraCath(TM) Continuous Nerve Block Kit - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: UltraCath(TM) Continuous Nerve Block Kit

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More Product Details

Catalog Number

UC-19611-KPU

Brand Name

ARROW

Version/Model Number

IPN048795

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162522,K162522

Product Code Details

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Device Record Status

Public Device Record Key

dbc0d30b-3b35-4856-b45a-14e79429aa78

Public Version Date

April 21, 2021

Public Version Number

3

DI Record Publish Date

November 09, 2018

Additional Identifiers

Package DI Number

30801902134548

Quantity per Package

5

Contains DI Package

40801902134545

Package Discontinue Date

April 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Case

"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