SS650

GUDID 08800046051484

GNI Co.,Ltd

Intraoral optical scanning system
Primary Device ID08800046051484
NIH Device Record Key3d610d3f-761b-402e-b0c0-115286a1c4bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSS650
Version Model NumberSS650
Company DUNS694828541
Company NameGNI Co.,Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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
GS108800046051484 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


[08800046051484]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-14
Device Publish Date2025-04-04

Devices Manufactured by GNI Co.,Ltd

08800046051484 - SS6502025-04-14
08800046051484 - SS6502025-04-14
08800046051309 - SSBC-M22-464G2024-06-26
08800046051316 - SSBC-M22-364G2024-06-26
08800046051323 - SSBC-M22-264G2024-06-26
08800046051330 - SSBC-M22-164G2024-06-26
08800046051385 - SSBC-M22-1M44G2024-06-26
08800046027540 - IES1-10012024-06-12
08800046045896 - P01-012024-06-12

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.