Instrument Tray for Ex Hex Medical Device Identification

GUDID 06009544011088

Instrument Tray for Ex Hex

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray

Primary Device ID	06009544011088
NIH Device Record Key	40001e68-1045-4cdb-a66e-a85b30d1bb3d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	I-EXT-HEX-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	06009544011088 [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

[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 Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-12-28
Device Publish Date	2018-11-27

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544038313 - NA	2025-03-20 Instrument Hand Piece insert tool CoAxis TN 5.0 GS
06009544050209 - NA	2025-02-03 Compact Conical Abutment for Ø3.5 / Ø4.0 DC, 30° Angled 3.5mm collar height
06009544041450 - N/A	2025-01-31 Scan Flag Ti ø3.3 PRO
06009544038306 - NA	2025-01-30 Handpiece Insertion Tool for Ø4.3 Tri-Nex Co-Axis Guided Surgery
06009544038955 - NA	2025-01-30 Sleeve Guided Surgery 06.2 x 4mm
06009544048930 - N/A	2025-01-28 Instr Drill Ext GS ø5.1 Offset 10.5
06009544049074 - N/A	2025-01-28 Insertion Tool Int Hex BG
06009544049098 - N/A	2025-01-28 Instr H/P Insert Tool PRO3 BG

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.