GUDID 06009544048015

Instrument Tray Pterygoid Milled

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray, reusable
Primary Device ID06009544048015
NIH Device Record Keyebd2f214-2c40-4dc7-ba65-1e165d306fac
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberI-PT-MT
Company DUNS636239584
Company NameSOUTHERN IMPLANTS (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106009544048015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


[06009544048015]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-24
Device Publish Date2024-07-16

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544048015 - NA2024-07-24Instrument Tray Pterygoid Milled
06009544048015 - NA2024-07-24 Instrument Tray Pterygoid Milled
06009544037491 - N/A2024-06-18 Screw PA Abut PRO M1.6 Titanium
06009544038276 - N/A2024-06-18 Screw PA Abut PRO M16 Brass
06009544045274 - N/A2024-06-07 Implant Inverta MSc DC30 Ø3.75x8
06009544045281 - N/A2024-06-07 Implant Inverta MSc DC30 Ø3.75x10
06009544045298 - N/A2024-06-07 Implant Inverta MSc DC30 Ø3.75x13
06009544045304 - N/A2024-06-07 Implant Inverta MSc DC30 Ø3.75x11.5
06009544045311 - N/A2024-06-07 Implant Inverta MSc DC30 Ø3.75x15

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