OT EQUATOR-OT BRIDGE - Device for laboratory use that allows to - RHEIN 83 SRL

Duns Number:439240722

Device Description: Device for laboratory use that allows to replicate the position and geometry of the attach

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More Product Details

Catalog Number

144AVC4

Brand Name

OT EQUATOR-OT BRIDGE

Version/Model Number

ANALOG Ø4 W/SCREW FOR CAD/CAM MODEL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

208bd945-be3a-411a-8c82-7aa957fef3af

Public Version Date

February 22, 2021

Public Version Number

2

DI Record Publish Date

October 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RHEIN 83 SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1269
2 A medical device with a moderate to high risk that requires special controls. 1987