AccuStat

GUDID 00878953000121

125um Fiber

AMERICAN MEDICAL SYSTEMS

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable

Primary Device ID	00878953000121
NIH Device Record Key	b466c277-e68f-4a68-b79c-4f34560e56b5
Commercial Distribution Status	In Commercial Distribution
Brand Name	AccuStat
Version Model Number	0010-6110
Company DUNS	796308653
Company Name	AMERICAN MEDICAL SYSTEMS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953000121 [Primary]

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-02-13
Device Publish Date	2016-09-24

On-Brand Devices [AccuStat]

00878953000121	125um Fiber
00878953000114	100um Fiber

Trademark Results [AccuStat]

Mark Image Registration \| Serial	Company Trademark Application Date
ACCUSTAT 87917020 5617432 Live/Registered	RGF Environmental Group, Inc. 2018-05-11
ACCUSTAT 86864075 not registered Dead/Abandoned	Medline Industries, Inc. 2016-01-03
ACCUSTAT 79034030 not registered Dead/Abandoned	SAMES TECHNOLOGIES 2005-12-22
ACCUSTAT 77164797 3465393 Dead/Cancelled	AccuStat EMR 2007-04-24
ACCUSTAT 76661039 3241117 Dead/Cancelled	Accustat Carolinas, LLC 2006-06-05
ACCUSTAT 75229811 not registered Dead/Abandoned	Gates Corporation, The 1997-01-23
ACCUSTAT 75115608 2122961 Dead/Cancelled	ROCHE DIAGNOSTICS OPERATIONS, INC. 1996-06-07
ACCUSTAT 74663055 not registered Dead/Abandoned	BOEHRINGER MANHEIM CORPORATION 1995-04-12
ACCUSTAT 74372795 1814725 Dead/Cancelled	FANUC ROBOTICS AMERICA, INC. 1993-03-29
ACCUSTAT 73705930 1512475 Dead/Cancelled	ABBOTT LABORATORIES 1988-01-15
ACCUSTAT 73073124 1045330 Dead/Cancelled	PSG INDUSTRIES, INC. 1975-12-30