ARROW - FlexTip Plus(R) Combined Spinal - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: FlexTip Plus(R) Combined Spinal Anesthesia/Epidural Kit with NRFit(TM) connector

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

CSE19TAGSKG

Brand Name

ARROW

Version/Model Number

IPN048030

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

K140110,K140110

Product Code Details

Product Code

BSO

Product Code Name

CATHETER, CONDUCTION, ANESTHETIC

Device Record Status

Public Device Record Key

a280c012-c01e-4c38-82b6-429e0e49c475

Public Version Date

July 16, 2021

Public Version Number

6

DI Record Publish Date

November 09, 2018

Additional Identifiers

Package DI Number

40801902130738

Quantity per Package

10

Contains DI Package

30801902130731

Package Discontinue Date

-

Package Status

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