GUDID 06009544003793

Tapered Drill for Ø5.0 ITT, Ø4.6 x 14.5mm

SOUTHERN IMPLANTS (PTY) LTD

Fixture/appliance dental drill bit, reusable
Primary Device ID06009544003793
NIH Device Record Key6f96d697-36ee-4395-a6fa-120e2146ed3b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberD-514T
Company DUNS636239584
Company NameSOUTHERN IMPLANTS (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS106009544003793 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


[06009544003793]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-09
Device Publish Date2018-11-21

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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
06009544048640 - N/A2024-09-03 Implant SP1 Ø4.0x22mm
06009544048657 - N/A2024-09-03 Implant SP1 Ø4.0x24mm
06009544039785 - N/A2024-08-30 Cortical Perforator Drill for Guided Surgery ø4.1

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