Instrument Tray, Prosthetic Medical Device Identification

GUDID 06009544012856

Instrument Tray, Prosthetic

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray

Primary Device ID	06009544012856
NIH Device Record Key	08b1de4d-fcef-4405-a6bd-1d9ae3a01b81
Commercial Distribution Status	In Commercial Distribution
Version Model Number	I-PROS-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	06009544012856 [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

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

Moist Heat or Steam Sterilization

[06009544012856]

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	2018-11-30

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544040064 - N/A	2025-05-05 Instr H/P Oct Int Drive GS
06009544012115 - N/A	2025-05-02 Converter and Extention Instr
06009544039990 - N/A	2025-05-02 Instrument Space Maintainer CC 4.8x6
06009544040774 - N/A	2025-05-02 O-Ring DC3 Insertion Tools MP5
06009544050353 - NA	2025-05-01 Compact Conical Abutment for 17° Ø4 ExHex Ø4.8x3mm
06009544050360 - NA	2025-05-01 Compact Conical Abutment for 17° Ø4 ExHex Ø4.8x4mm
06009544048947 - ZAGA™	2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 30.0mm
06009544048954 - ZAGA™	2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 32.5mm

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