GIGAA

GUDID 06970460900001

Wuhan Gigaa Optronics Technology Co.,Ltd.

General/multiple surgical diode laser system
Primary Device ID06970460900001
NIH Device Record Key707173d4-4149-47b7-9f6d-49c83a98f24c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGIGAA
Version Model NumberVELASⅡ-15D
Company DUNS529611032
Company NameWuhan Gigaa Optronics Technology 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 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
GS106970460900001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-15
Device Publish Date2018-09-14

On-Brand Devices [GIGAA]

06970460900070VELASⅡ-60C
06970460900063VELASⅡ-60B
06970460900056VELASⅡ-60A
06970460900049VELASⅡ-30B
06970460900032VELASⅡ-30A
06970460900025GBOX-15B
06970460900018GBOX-15A
06970460900001VELASⅡ-15D
06974632230019VELAII-15D

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