Alef Spiral Implant AL4211

GUDID 07290018434130

MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD

Dental implant system
Primary Device ID07290018434130
NIH Device Record Key78e02d85-bee3-4638-a226-41215eaf2337
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlef Spiral Implant
Version Model Number4.2 x 11.5
Catalog NumberAL4211
Company DUNS531825934
Company NameMEDICAL SYSTEMS AND DEVICES INTERNATIONAL 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 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
GS107290018434130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-31
Device Publish Date2024-01-23

On-Brand Devices [Alef Spiral Implant]

072900184342606.0 x 13
072900184342536.0 x 11.5
072900184342466.0 x 10
072900184342396.0 x 8
072900184342155.0 x 16
072900184342085.0 x 13
072900184341925.0 x 11.5
072900184341855.0 x 10
072900184341785.0 x 8
072900184341544.2 x 16
072900184341474.2 x 13
072900184341304.2 x 11.5
072900184341234.2 x 10
072900184341164.2 x 8
072900184340933.75 x 16
072900184340863.75 x 13
072900184340793.75 x 11.5
072900184340623.75 x 10
072900184340553.75 x 8
072900184340483.5 x 16
072900184340313.5 x 13
072900184340243.5 x 11.5
072900184340173.5 x 10
072900184340003.5 x 8

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