Accent XLi Unilarge Thermometer Handpiece AAUN01051204

GUDID 17290110120068

ALMA LASERS LTD.

Ultrasonic hyperthermia system
Primary Device ID17290110120068
NIH Device Record Key6fc198f5-40b8-4819-b673-305552dd263d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccent XLi Unilarge Thermometer Handpiece
Version Model Number1
Catalog NumberAAUN01051204
Company DUNS532283264
Company NameALMA LASERS LTD.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290110120068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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