SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III

GUDID 00817495024462

SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III

Candela Corporation

Multi-modality skin contouring system
Primary Device ID00817495024462
NIH Device Record Key296ad009-66bf-473f-a408-2c3bd269657f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
Version Model NumberAS83333
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100817495024462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUVMassager, Vacuum, Light Induced Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

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