Bare Fiber 2.1 200

GUDID 04058784000293

Single use optical fiber for surgery

Asclepion Laser Technologies GmbH

General/multiple surgical laser system beam guide, single-use, sterile General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use General/multiple surgical laser system beam guide, single-use
Primary Device ID04058784000293
NIH Device Record Key76cc42dc-835d-4401-9cc9-fdcbac530172
Commercial Distribution StatusIn Commercial Distribution
Brand NameBare Fiber 2.1 200
Version Model Number2954
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 Usetrue
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

Customer Support Contacts

Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com
Phone+4936417700401
Emailservice@asclepion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104058784000293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-03-01

Devices Manufactured by Asclepion Laser Technologies GmbH

04058784001115 - MultiCut Solo2023-02-27
04058784000989 - PicoStar2022-06-21 Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for tattoo removal and the treatment of be
04058784001078 - PicoStar2022-06-21 Device with Nd:YAG laser (including frequency doubling) up to 800 mJ 1064 nm & 532 nm for tattoo removal and the treatment of be
04058784001023 - MultiPulse HoPLUS2020-09-02 Holmium Laser for Surgery
04058784001054 - MultiPulse HoPLUS2020-09-02 Holmium Laser for Surgery
04058784000279 - MeDioStar2020-04-06 Dermatological laser with wavelengths of 755 - 950 nm. Intended for hair removal, permanent hair reduction and the treatment of
04058784000132 - TattooStar2020-02-06
04058784000996 - MultiPulse HoPLUS2019-12-11 Holmium Laser for Surgery

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