GUDID 06009544048695

Implant ExHex Wide ZYGIN Ø4.3x35mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece
Primary Device ID06009544048695
NIH Device Record Key913a6f80-b319-452a-b745-0ade0a1f47be
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberZYGIN-W-35
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
GS106009544048695 [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

06009544048671 - NA2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x30mm
06009544048688 - NA2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x32.5mm
06009544048695 - NA2024-12-19Implant ExHex Wide ZYGIN Ø4.3x35mm
06009544048695 - NA2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x35mm
06009544048701 - NA2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x37.5mm
06009544048718 - NA2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x40mm
06009544048725 - NA2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x42.5mm
06009544048732 - NA2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x45mm
06009544048749 - NA2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x47.5mm

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