Catalog Number

-

Brand Name

rematitan®

Version/Model Number

768-119-00

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

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

K935140,K935140

Product Code

DZC

Product Code Name

WIRE, ORTHODONTIC

Public Device Record Key

46fb8315-a71e-4e08-a5b9-5773a8ac64d8

Public Version Date

August 29, 2019

Public Version Number

1

DI Record Publish Date

August 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-