GUDID 06009544011088

Instrument Tray for Ex Hex

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray
Primary Device ID06009544011088
NIH Device Record Key40001e68-1045-4cdb-a66e-a85b30d1bb3d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberI-EXT-HEX-EG
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
GS106009544011088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


[06009544011088]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-28
Device Publish Date2018-11-27

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544000105 - NA2025-07-17 Abutment Healing Int Hex PM 6.5x6
06009544050438 - N/A2025-07-17 Abutment Healing SP1 ø3.8x2.5mm
06009544050445 - N/A2025-07-17 Abutment Healing SP1 ø3.8x3.5mm
06009544050452 - N/A2025-07-17 Abutment Healing SP1 ø3.8x4.5mm
06009544050469 - N/A2025-07-17 Abutment Healing SP1 ø3.8x5.5mm
06009544050476 - N/A2025-07-17 Abutment Healing SP1 ø3.8x6.5mm
06009544050483 - N/A2025-07-17 Abutment Healing SP1 ø4.5x6.5mm
06009544050490 - N/A2025-07-17 Abutment Healing SP1 ø5.0x6.5mm

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