06009544031048 Medical Device Identification

GUDID 06009544031048

Titanium Abutment Base for Ø3.5 Tri-Nex, 1.5mm Collar, Non-Engaging

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

Primary Device ID	06009544031048
NIH Device Record Key	bf8d813e-89c2-4fbc-bad6-2e4fed139e4f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	TIB-NL-35-C1.5
Company DUNS	636239584
Company Name	SOUTHERN IMPLANTS (PTY) LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
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	06009544031048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K070905
Premarket Notification: K193084

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

[06009544031048]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-11-08
Device Publish Date	2019-01-09

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544038252 - NA	2024-11-06 Screw Ti Hex Series L3.5mm
06009544039952 - N/A	2024-11-01 Screw Titanium Hex 1 Series ø2.7 Head
06009544039969 - N/A	2024-11-01 Screw Ti Hexed M1.4 NLT
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

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