GUDID 06009544011057

Ext. Hex Cylindrical Implant, Ultra-Short, Ø3.75 x 4mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant Facial prosthesis attachment implant
Primary Device ID06009544011057
NIH Device Record Key1d652abf-4d4c-4367-a447-4bc0cbe265b9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberIE4
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106009544011057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZEProsthesis, Nose, Internal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-15
Device Publish Date2019-01-15

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