Catalog Number

AM0010

Brand Name

ARISTA AH FlexiTip XL-R

Version/Model Number

AM0010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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"

-

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

P050038,P050038

Product Code

LMG

Product Code Name

Agent, absorbable hemostatic, non-collagen based

Public Device Record Key

9b5d672b-bae9-4e59-88df-8128dc0c7a20

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 25, 2016

Package DI Number

10801741096805

Quantity per Package

10

Contains DI Package

00801741096808

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA