Instrument Tray for Int. Hex Medical Device Identification

GUDID 06009544012092

Instrument Tray for Int. Hex

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray

Primary Device ID	06009544012092
NIH Device Record Key	bd076b63-f4d8-46bd-89d6-1e975ed350eb
Commercial Distribution Status	In Commercial Distribution
Version Model Number	I-INT-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	06009544012092 [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

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

Moist Heat or Steam Sterilization

[06009544012092]

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

06009544048589 - N/A	2024-09-03 Implant SP1 Ø4.0x10mm
06009544048596 - N/A	2024-09-03 Implant SP1 Ø4.0x11mm
06009544048619 - N/A	2024-09-03 Implant SP1 Ø4.0x15mm
06009544048626 - N/A	2024-09-03 Implant SP1 Ø4.0x18mm
06009544048633 - N/A	2024-09-03 Implant SP1 Ø4.0x20mm
06009544048640 - N/A	2024-09-03 Implant SP1 Ø4.0x22mm
06009544048657 - N/A	2024-09-03 Implant SP1 Ø4.0x24mm
06009544039785 - N/A	2024-08-30 Cortical Perforator Drill for Guided Surgery ø4.1

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