Canister HFO-R1234 ZE / 950g, ALUM, 15 Pack (Japan)

GUDID 00817495025025

Canister HFO-R1234 ZE / 950g, ALUM, 15 Pack (Japan)

Candela Corporation

Dermatological solid-state laser system
Primary Device ID00817495025025
NIH Device Record Key250d059d-1bf7-40ff-b74a-1d28e99ba3f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCanister HFO-R1234 ZE / 950g, ALUM, 15 Pack (Japan)
Version Model NumberFIN101112
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
GS100817495025025 [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 Date2024-02-12
Device Publish Date2024-02-02

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