Catalog Number

131ILG4

Brand Name

OT EQUATOR - OT BRIDGE

Version/Model Number

OT EQUATOR Flat One Gold & Blu h.4 c/SB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

ef365758-336d-48fe-9b4e-dd25a2f7ddfc

Public Version Date

January 27, 2021

Public Version Number

2

DI Record Publish Date

December 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-