Alex 755 Delivery System Demo

GUDID 00817495022123

Delivery System Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator Laser skin surface treatment system applicator
Primary Device ID00817495022123
NIH Device Record Keyfc52603c-b836-4da3-8cac-1bf5aab6975d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlex 755 Delivery System Demo
Version Model Number0800-00-1093
Company DUNS053468385
Company NameCANDELA CORPORATION
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
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS100817495022123 [Primary]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]
GS108174950202127 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument
GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-17
Device Publish Date2016-09-23

On-Brand Devices [Alex 755 Delivery System Demo]

00817495022130Delivery System Assembly
00817495022123Delivery System Assembly

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