ARROW - StimuQuik(R) Echo Insulated Peripheral Nerve - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: StimuQuik(R) Echo Insulated Peripheral Nerve Block Needle

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More Product Details

Catalog Number

AB-21090-SSE

Brand Name

ARROW

Version/Model Number

IPN045594

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

K173321,K173321,K173321

Product Code Details

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Device Record Status

Public Device Record Key

aca5211c-ba44-4a26-9844-917df9676b78

Public Version Date

September 03, 2021

Public Version Number

7

DI Record Publish Date

March 01, 2019

Additional Identifiers

Package DI Number

30801902114106

Quantity per Package

25

Contains DI Package

40801902114103

Package Discontinue Date

September 02, 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