MultiPulse HoPLUS J19-1161-000

GUDID 04058784001009

Holmium Laser for Surgery

Asclepion Laser Technologies GmbH

General/multiple surgical solid-state laser system
Primary Device ID04058784001009
NIH Device Record Key40986881-0664-433f-80fa-c91d7a742b9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMultiPulse HoPLUS
Version Model NumberJ19-1161-000
Catalog NumberJ19-1161-000
Company DUNS332247852
Company NameAsclepion Laser Technologies GmbH
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4936417700401
Emailservice@asclepion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104058784001009 [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 Date2019-12-10
Device Publish Date2019-12-02

On-Brand Devices [MultiPulse HoPLUS]

04058784001009Holmium Laser for Surgery
04058784000996Holmium Laser for Surgery
04058784001054Holmium Laser for Surgery
04058784001023Holmium Laser for Surgery

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