UNIVERSAL UNIT MU-TPC

GUDID 07290110728069

SLEEVE

HI-TEC IMPLANTS LTD.

Dental implant system
Primary Device ID07290110728069
NIH Device Record Key5bc7c3b2-950c-4a76-802f-1ab81de6e105
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIVERSAL UNIT
Version Model NumberMU-TPC
Catalog NumberMU-TPC
Company DUNS600710917
Company NameHI-TEC IMPLANTS LTD.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110728069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-14

On-Brand Devices [UNIVERSAL UNIT]

07290110728168CAD CAM ABUTMENT
07290110728151TOOL
07290110728144TOOL
07290110728137TOOL
07290110728120ABUTMENT ANALOG
07290110728113SLEEVE
07290110728106TRANSFER
07290110728090TRANSFER
07290110728083FIXATION SCREW
07290110728076FIXATION SCREW
07290110728069SLEEVE
07290110728052SLEEVE
07290110728045HEALING CAP

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