BVI OME6001

GUDID 00886158037576

Leos laser and endoscopy console

Beaver-Visitec International, Inc.

Endoscopic-imaging ophthalmic solid-state laser system
Primary Device ID00886158037576
NIH Device Record Keya1f3c533-d8e9-4eb8-bcab-e231ca480b5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBVI
Version Model NumberOME6001U
Catalog NumberOME6001
Company DUNS001406024
Company NameBeaver-Visitec International, 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 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+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com
Phone+1(866)906-8080
Emailcustomersupport@bvimedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100886158037576 [Primary]

FDA Product Code

HQPUnit, cautery, thermal, battery-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-30
Device Publish Date2025-07-22

On-Brand Devices [BVI]

00886158037576Leos laser and endoscopy console
00886158037569Leos footswitch, main assembly
0088615803468119G VueProbe, Curved, 1 pack
0088615803467419G VueProbe, Straight, 1 pack
00886158034247Leos footswitch

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