ARROW - FlexTip Plus(R) Epidural Catheterization Kit - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: FlexTip Plus(R) Epidural Catheterization Kit

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More Product Details

Catalog Number

MP-17019-HKL

Brand Name

ARROW

Version/Model Number

IPN046490

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K140110,K140110,K140110

Product Code Details

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Device Record Status

Public Device Record Key

f8a920d3-8025-4ec6-a8f8-c214ebb34c36

Public Version Date

September 29, 2021

Public Version Number

6

DI Record Publish Date

July 25, 2018

Additional Identifiers

Package DI Number

10801902070149

Quantity per Package

5

Contains DI Package

20801902070146

Package Discontinue Date

September 28, 2021

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