GUDID 06009544000815

Compact Conical Abutment for Ø4.0 Ex Hex, Z-Series, Ø4.8 x 1.5mm

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID06009544000815
NIH Device Record Key7a7ed022-c597-4bfd-b149-b171894554db
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAMCZ1
Company DUNS636239584
Company NameSOUTHERN IMPLANTS (PTY) 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106009544000815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-01-08

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