Guided Ti Sleeve GDSS

GUDID 07290019897354

MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD

Dental implant system
Primary Device ID07290019897354
NIH Device Record Key25177c69-d5d5-4601-8f1b-d29ef165a532
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuided Ti Sleeve
Version Model NumberAL TP
Catalog NumberGDSS
Company DUNS531825934
Company NameMEDICAL SYSTEMS AND DEVICES INTERNATIONAL 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 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
GS107290019897354 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


[07290019897354]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-06
Device Publish Date2024-01-29

Devices Manufactured by MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD

07290019897620 - Ratchet click driver long2024-02-07
07290019897675 - Implant hand driver short2024-02-07
07290019897019 - Implant hand driver long2024-02-06
07290019897026 - Motor mount click driver long2024-02-06
07290019897071 - Motor mount click driver short 2024-02-06
07290019897125 - Motor mount click driver long2024-02-06
07290019897156 - Guided ratchet driver long2024-02-06
07290019897170 - Motor mount click driver short 2024-02-06

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