Catalog Number

187401

Brand Name

Border-Lock® Green Mouldable Upper Dentulous Tray

Version/Model Number

187401

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EHY

Product Code Name

TRAY, IMPRESSION, PREFORMED

Public Device Record Key

e10151ae-6205-4be7-9caa-39db05545323

Public Version Date

March 27, 2020

Public Version Number

1

DI Record Publish Date

March 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-