Instrument Tray for MAX Medical Device Identification

GUDID 06009544012429

Instrument Tray for MAX

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray

Primary Device ID	06009544012429
NIH Device Record Key	4ac313e6-b5c5-4daa-8a4a-efd51f4dd66d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	I-MAX-EG
Company DUNS	636239584
Company Name	SOUTHERN IMPLANTS (PTY) LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009544012429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K210923

FDA Product Code

KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
NDP	Accessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

[06009544012429]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-12-31
Device Publish Date	2018-11-29

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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06009544047827 - N/A	2025-11-25 Titanium Blank for Ø3.0 DC, Ø11.5mm
06009544047834 - N/A	2025-11-25 Titanium Blank for Ø3.5/Ø4.0 DC, Ø11.5mm
06009544047841 - N/A	2025-11-25 Titanium Blank for Ø5.0 DC , Ø11.5mm
06009544047858 - N/A	2025-11-25 Titanium Blank for Ø3.5 Tri-Nex, Ø11.5mm
06009544047865 - N/A	2025-11-25 Titanium Blank for Ø4.3 Tri-Nex, Ø11.5mm
06009544047872 - N/A	2025-11-25 Titanium Blank for Ø5.0 Tri-Nex, Ø11.5mm
06009544047889 - N/A	2025-11-25 Titanium Blank for Ø6.0 Tri-Nex, Ø11.5mm

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