GUDID 06009544044123

Instrument Tray SP1 GS 8-13mm

SOUTHERN IMPLANTS (PTY) LTD

Instrument tray, reusable
Primary Device ID06009544044123
NIH Device Record Key74bb7dc1-9db1-425e-b37b-db25732be3a9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberI-SP-GS1-EG
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
GS106009544044123 [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

[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


[06009544044123]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-11
Device Publish Date2024-03-01

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