Instrument Tray for Tri-Nex Medical Device Identification

GUDID 06009544013631

Instrument Tray for Tri-Nex

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray

Primary Device ID	06009544013631
NIH Device Record Key	34da0660-4d09-4921-934f-5c56f36b66b5
Commercial Distribution Status	In Commercial Distribution
Version Model Number	I-TRI-NEX-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	06009544013631 [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

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

[06009544013631]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-01-01
Device Publish Date	2018-12-01

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544026266 - NA	2025-12-29 Torx Titanium Screw for IT, Angulated Screw Channel
06009544050919 - N/A	2025-12-29 Angulated Screw Channel Abutment, Engaging, for Ø5.0 DC
06009544050926 - N/A	2025-12-29 Angulated Screw Channel Abutment, Engaging, for IT
06009544050957 - N/A	2025-12-26 Guided Surgery Sleeve, OD Ø5.1 / ID Ø4.2 x 4mm
06009544050964 - N/A	2025-12-26 Guided Surgery Sleeve, OD Ø5.2 / ID Ø4.2 x 6mm
06009544050971 - N/A	2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / ID Ø5.2 x 4mm
06009544050988 - N/A	2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / Ø5.2 x 6mm
06009544050995 - N/A	2025-12-26 Guided Surgery Sleeve, OD Ø6.2 / ID Ø5.2 x 4mm, Multipack x5

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