Stellar Image Processing Unit

GUDID 06973031299436

Guangdong Optomedic Technologies, Inc.

Endoscopic video image processing unit
Primary Device ID06973031299436
NIH Device Record Key89db4d33-33fd-4fe8-b52e-8c58c687a836
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellar Image Processing Unit
Version Model NumberSI10E
Company DUNS544527790
Company NameGuangdong Optomedic Technologies, Inc.
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 Batchfalse
Serial Numbertrue
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
GS106973031299436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-23
Device Publish Date2024-08-15

Devices Manufactured by Guangdong Optomedic Technologies, Inc.

06973031299337 - 3D Laparoscope2024-08-23
06973031299344 - 3D Laparoscope2024-08-23
06973031299375 - Stellar Light Source 2024-08-23
06973031299382 - Stellar Exoscope2024-08-23
06973031299399 - Stellar 3D Fluorescence Camera Head2024-08-23
06973031299405 - Stellar 3D Camera Head2024-08-23
06973031299412 - Stellar Fluorescence Camera Head2024-08-23
06973031299429 - Stellar Camera Head2024-08-23

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