GUDID 06009544009146

Temporary Healing Cap for Ø4.8 Compact Conical, Ø7.0 x 4mm

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID06009544009146
NIH Device Record Key63edd9e5-3eb3-49aa-9850-cf0cceeb0e0c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberHMCT7-4
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106009544009146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-08
Device Publish Date2019-01-08

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

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