Acculite EndoOto

GUDID 07290109140841

LUMENIS INC.

Ophthalmic laser system beam guide
Primary Device ID07290109140841
NIH Device Record Keyc6c8a999-eb0b-4d0e-b563-b4ac36c5cf32
Commercial Distribution Discontinuation2020-02-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAcculite EndoOto
Version Model Number24ga 10° Angled, SMA 905, 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
GS107290109140841 [Primary]
GS117290109140848 [Package]
Package: [10 Units]
Discontinued: 2020-02-21
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290109140841]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-09-26

On-Brand Devices [Acculite EndoOto]

1729010914085524ga 15° Angled, SMA 905, 200µm
0729010914084124ga 10° Angled, SMA 905, 200µm
17290109140831Horn, 24ga 20° Angled, SMA 906, 200µm
07290109140827Gherini, 24ga Straight, SMA 906, 200µm

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