Catalog Number

54001185

Brand Name

DTK adhesive assortment

Version/Model Number

54001185

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KOL

Product Code Name

ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (32%) AND ETHYLENE-OXIDE HOMOPOLYMER

Public Device Record Key

1daf33a9-4a6d-4d17-bf9d-e85357041b60

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2016

Package DI Number

EBRE540011859

Quantity per Package

1

Contains DI Package

EBRE540011850

Package Discontinue Date

September 27, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy