GUDID 06009544041580

Torx Titanium Screw for Int. Hex, Angulated Screw Channel

SOUTHERN IMPLANTS (PTY) LTD

Dental prosthesis/implant abutment screw
Primary Device ID06009544041580
NIH Device Record Keyb4d8a09f-ef21-4628-8a70-6d1c8ac41e6f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTS-Z-18-ASC
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
GS106009544041580 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-09
Device Publish Date2023-03-01

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544038252 - NA2024-11-06 Screw Ti Hex Series L3.5mm
06009544039952 - N/A2024-11-01 Screw Titanium Hex 1 Series ø2.7 Head
06009544039969 - N/A2024-11-01 Screw Ti Hexed M1.4 NLT
06009544048589 - N/A2024-09-03 Implant SP1 Ø4.0x10mm
06009544048596 - N/A2024-09-03 Implant SP1 Ø4.0x11mm
06009544048619 - N/A2024-09-03 Implant SP1 Ø4.0x15mm
06009544048626 - N/A2024-09-03 Implant SP1 Ø4.0x18mm
06009544048633 - N/A2024-09-03 Implant SP1 Ø4.0x20mm

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