Catalog Number

-

Brand Name

Montesol

Version/Model Number

044F6008

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KCJ

Product Code Name

Applicator, Ent

Public Device Record Key

d499c9b0-c1c5-431f-8ae7-e731c67dd8d8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 05, 2016

Package DI Number

00744229100522

Quantity per Package

12

Contains DI Package

00744229440758

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton