Delivery Unit 41000008349

GUDID 07899581343414

Delivery Unit Syncrus G8 FE

Alliage S/A Indústrias Médico Odontológica

Dental delivery system
Primary Device ID07899581343414
NIH Device Record Keydebb5dc0-8ac9-4e48-a7bf-ab957c9b33a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDelivery Unit
Version Model NumberSyncrus G8 FE
Catalog Number41000008349
Company DUNS898231451
Company NameAlliage S/A Indústrias Médico Odontológica
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899581343414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUnit, Operative Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-08
Device Publish Date2025-12-31

On-Brand Devices [Delivery Unit]

07899581343599Delivery Unit Syncrus G8 HE
07899581343414Delivery Unit Syncrus G8 FE
07899581343186Delivery Unit Syncrus G3 H
07899581342844Delivery Unit Syncrus G3
07899581342707Delivery Unit Syncrus G2

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