VBeam Prima DCD Delivery System

GUDID 08174950202820

Delivery System Assembly

CANDELA CORPORATION

Laser skin surface treatment system applicator
Primary Device ID08174950202820
NIH Device Record Key29b0189f-8c22-4e9c-b9a6-b9692099b209
Commercial Distribution StatusIn Commercial Distribution
Brand NameVBeam Prima DCD Delivery System
Version Model Number7123-00-0433
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

Customer Support Contacts

Phone800-733-8550
Emailcustomer.service@candelamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108174950202820 [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 Date2019-12-20
Device Publish Date2019-12-12

On-Brand Devices [VBeam Prima DCD Delivery System]

08174950202820Delivery System Assembly
00817495023014Delivery System Assembly

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