Packaged 15-Pack of Cryogen (R134a / 980g / US)

GUDID 00817495020587

Packaged 15-Pack of Cryogen (R134a / 980g / US)

Candela Corporation

Dermatological solid-state laser system
Primary Device ID00817495020587
NIH Device Record Key4f926336-4595-464c-a03a-2b12dba1404c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePackaged 15-Pack of Cryogen (R134a / 980g / US)
Version Model Number1600-00-0219
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495020587 [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 Date2024-05-06
Device Publish Date2024-04-26

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