Catalog Number

TPPR12

Brand Name

Integra® Miltex®

Version/Model Number

TPPR12

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EMS

Product Code Name

CURETTE, PERIODONTIC

Public Device Record Key

1bc1d1c1-5ba4-4a65-84a5-b4d1012117d8

Public Version Date

July 21, 2020

Public Version Number

5

DI Record Publish Date

April 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-