Catalog Number

852-032960

Brand Name

Lingual Sheaths

Version/Model Number

852-032960

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

ECN

Product Code Name

CLAMP, WIRE, ORTHODONTIC

Public Device Record Key

158e9380-4d8a-47b9-9559-713a7ee581f3

Public Version Date

June 23, 2020

Public Version Number

1

DI Record Publish Date

June 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-