OT EQUATOR - OT BRIDGE 131AEV31

GUDID 08059224151076

DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection and the thread are compatible with the specific implant; available in different cuff heights. Retentive caps of different retentive forces, metal housing for the caps and protective disc.

RHEIN 83 SRL

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID08059224151076
NIH Device Record Key0121f9fc-f867-4067-a998-30a90b6e31d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOT EQUATOR - OT BRIDGE
Version Model NumberOT EQUATOR ASTRA EV ø 3 h.1 c/SB
Catalog Number131AEV31
Company DUNS439240722
Company NameRHEIN 83 SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108059224151076 [Primary]
HIBCCD821131AEV31 [Previous]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


[08059224151076]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-21
Device Publish Date2021-07-13

On-Brand Devices [OT EQUATOR - OT BRIDGE]

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