Laser Speckle Flowgraphy LSFG-NAVI

GUDID 04589662680035

SOFTCARE CO., LTD.

Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system Scanning-laser ophthalmic imaging system
Primary Device ID04589662680035
NIH Device Record Key9ed9b351-62f9-4ea5-a79b-e499c8d83c76
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaser Speckle Flowgraphy LSFG-NAVI
Version Model NumberLSFG-NAVI-NM2
Company DUNS711448795
Company NameSOFTCARE CO., 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 Usefalse
Lot Batchfalse
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
GS104589662680035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLIOphthalmoscope, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

On-Brand Devices [Laser Speckle Flowgraphy LSFG-NAVI]

04589662680028LSFG-NAVI-NM2
04589662680035LSFG-NAVI-NM2

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