GUDID 06009544048923

Implant ExHex ZYGON Ø3.7x60mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece
Primary Device ID06009544048923
NIH Device Record Key517a518d-9c77-4201-9b95-c32fdeed84e3
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberZYGON-60
Company DUNS636239584
Company NameSOUTHERN IMPLANTS (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS106009544048923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-19
Device Publish Date2024-12-11

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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