Guided Surgery Accessories Kit - UniFit Implants

GUDID 07290116770307

ADIN DENTAL IMPLANT SYSTEMS LTD

Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID07290116770307
NIH Device Record Keyc10b647e-e313-44b7-83cb-4d9053f13085
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuided Surgery Accessories Kit - UniFit Implants
Version Model NumberGSK005
Company DUNS533289435
Company NameADIN DENTAL IMPLANT SYSTEMS LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290116770307 [Primary]

FDA Product Code

OFYDental Implant Surgical Tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


[07290116770307]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-15
Device Publish Date2024-01-07

Devices Manufactured by ADIN DENTAL IMPLANT SYSTEMS LTD

07290109308746 - NP Straight Single TMA 1mm2024-02-12
07290109308753 - NP Straight Single TMA 2mm2024-02-12
07290109308760 - NP Straight Single TMA 3mm2024-02-12
07290109308777 - NP Angled Single TMA 17° 3mm2024-02-12
07290109308784 - NP Angled Single TMA 30° 3.5mm2024-02-12
07290109308791 - NP Angled Single TMA 30° 5mm2024-02-12
07290109308807 - NP Angled Single TMA 17° 4mm2024-02-12
07290109308814 - NP Straight Single TMA 4mm2024-02-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.