FEMTO LDV 510.002.003

GUDID 07640167750054

SIE AG, Surgical Instrument Engineering

Femtosecond ophthalmic solid-state laser system
Primary Device ID07640167750054
NIH Device Record Keyaec80e0f-0fca-4629-9dd0-8b66335c809e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFEMTO LDV
Version Model Numbermed-profile
Catalog Number510.002.003
Company DUNS482163628
Company NameSIE AG, Surgical Instrument Engineering
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8667084490
Emailusa@ziemergroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 millibar and 1080 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS107640167750054 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

On-Brand Devices [FEMTO LDV]

07640167750054med-profile
07640167750047Z2
07640167750030Z4
07640167750023Z6

Trademark Results [FEMTO LDV]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FEMTO LDV
FEMTO LDV
79288630 not registered Live/Pending
Ziemer Ophthalmic Systems AG
2020-04-02

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