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

Duns Number:002348191

Device Description: FlexTip Plus(R) Epidural Catheterization Kit

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


More Product Details

Catalog Number

ASK-05502-VM1

Brand Name

ARROW

Version/Model Number

IPN045706

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

-

Product Code Details

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Device Record Status

Public Device Record Key

9618671e-a5e4-43ce-bde4-ccc240135be6

Public Version Date

June 09, 2022

Public Version Number

9

DI Record Publish Date

October 17, 2018

Additional Identifiers

Package DI Number

10801902056303

Quantity per Package

10

Contains DI Package

20801902056300

Package Discontinue Date

June 06, 2022

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