Catalog Number

-

Brand Name

PREVI™ Isola Applicator Cartrige

Version/Model Number

PREVI™ Isola Applicator Cartrige

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

-

Product Code

LXG

Product Code Name

EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Public Device Record Key

6ddf5fb8-c9db-4b1d-9311-6d714862e8b9

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

June 26, 2020

Package DI Number

03573026219680

Quantity per Package

8

Contains DI Package

03573026613112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-