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

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
06009544048961 - ZAGA™	2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 35.0mm
06009544048978 - ZAGA™	2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 37.6mm
06009544048985 - ZAGA™	2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 40.0mm
06009544048992 - ZAGA™	2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 42.5mm
06009544049005 - ZAGA™	2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 45.0mm
06009544049012 - ZAGA™	2025-04-23 Straumann® Zygomatic Implant, Implant Zaga Flat 47.5mm

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