Acculite™  EndoOcular®

GUDID 07290109140742

LUMENIS INC.

Ophthalmic laser system beam guide
Primary Device ID07290109140742
NIH Device Record Key5514f037-6f62-47ec-aa17-710eef89f1ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcculite™  EndoOcular®
Version Model NumberStandard, 20ga 20° bend, SMA 906, 200µm
Company DUNS043618763
Company NameLUMENIS INC.
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

Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109140742 [Primary]
GS117290109140749 [Package]
Package: [10 Units]
Discontinued: 2016-09-12
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290109140742]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

On-Brand Devices [Acculite™  EndoOcular®]

17290109142781Standard, 20ga str taper, SmartScan, 200µm
17290109140800Illum/Sm Plug, 20ga 45°, SMA 906, 200µm
17290109140794Illum/Lg Plug, 20ga 45°, SMA 906, 200µm
17290109140770Illum/Lg Plug, 20ga str, SMA 906, 200µm
17290109140763Aspirating, 20ga str, SMA 906, 200µm
17290109140756" Aspirat., 20ga 45° bend, SMA 906, 200µm"
07290109140742Standard, 20ga 20° bend, SMA 906, 200µm
07290109140735Standard, 20ga str taper, SMA 906, 200μm
17290109140725Standard, 20ga str taper, SMA 905, 200µm

Trademark Results [Acculite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCULITE
ACCULITE
78769242 4043738 Dead/Cancelled
Juno Manufacturing, Inc.
2005-12-08
ACCULITE
ACCULITE
78732120 3186293 Live/Registered
Monobind, Inc.
2005-10-12
ACCULITE
ACCULITE
78318419 not registered Dead/Abandoned
Conair Corporation
2003-10-24
ACCULITE
ACCULITE
78076182 not registered Dead/Abandoned
HP INDUSTRIES, INC.
2001-07-27
ACCULITE
ACCULITE
77816438 3887552 Live/Registered
KibbeChem, Inc.
2009-08-31
ACCULITE
ACCULITE
77623489 3710305 Live/Registered
GLOBERIDE, INC.
2008-12-01
ACCULITE
ACCULITE
76154162 3841794 Live/Registered
CARLISLE INTERCONNECT TECHNOLOGIES, INC.
2000-10-26
ACCULITE
ACCULITE
75227027 not registered Dead/Abandoned
G. Loomis, Inc.
1997-01-16
ACCULITE
ACCULITE
74659025 2226944 Dead/Cancelled
SRF AMERICAS, INC.
1995-04-11
ACCULITE
ACCULITE
74329155 1777742 Dead/Cancelled
TENSOLITE COMPANY
1992-11-05
ACCULITE
ACCULITE
74312554 1775045 Dead/Cancelled
Accutron, Inc.
1992-09-10
ACCULITE
ACCULITE
74134761 1805398 Dead/Cancelled
TI Apollo Limited
1991-01-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.