FloNavi Camera Head

GUDID 06973031299825

Guangdong Optomedic Technologies, Inc.

Stationary general-purpose fluoroscopic x-ray system, digital
Primary Device ID06973031299825
NIH Device Record Key111a8278-5f5c-484f-9e81-ae2f6fc5ecbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameFloNavi Camera Head
Version Model NumberOPTO-CHD2100
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973031299825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06973031299825]

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[06973031299825]

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[06973031299825]

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[06973031299825]

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[06973031299825]

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[06973031299825]

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[06973031299825]

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[06973031299825]

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[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

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[06973031299825]

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[06973031299825]

High-level Disinfectant


[06973031299825]

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[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


[06973031299825]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-03
Device Publish Date2024-03-26

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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