Canister HFC-134a /980g, ALUM, 15 pack

GUDID 00817495023670

Canister HFC-134a /980g, ALUM, 15 pack

CANDELA CORPORATION

Dermatological solid-state laser system
Primary Device ID00817495023670
NIH Device Record Key5b421820-1c36-4af9-a7cf-068169b545b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCanister HFC-134a /980g, ALUM, 15 pack
Version Model Number1600-00-0224
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817495023670 [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 Date2022-10-03
Device Publish Date2022-09-23

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