FiberLase

GUDID 00860009714915

FiberLase GYN LAP-R Handpiece

TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

General/multiple surgical laser system beam guide, reusable
Primary Device ID00860009714915
NIH Device Record Key9212817f-dfbe-41ab-9fbe-c216f57493b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiberLase
Version Model NumberAC-1059620
Company DUNS130213366
Company NameTRANSAMERICAN TECHNOLOGIES INTERNATIONAL
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009714915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


[00860009714915]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-05-09
Device Publish Date2016-06-20

On-Brand Devices [FiberLase]

00860009714946SS FiberLase GYN LAP-S Handpiece
00860009714939SS FiberLase GYN LAP-R Handpiece
00860009714922Cleaning Kit for FiberLase GYN Lap Handpieces
00860009714915FiberLase GYN LAP-R Handpiece
00860009714908FiberLase GYN LAP-S Handpiece

Trademark Results [FiberLase]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FIBERLASE
FIBERLASE
74372304 1805940 Dead/Cancelled
Surgilase Inc.
1993-03-26
FIBERLASE
FIBERLASE
74343254 1789262 Dead/Cancelled
SHARPLAN LASERS, INC.
1992-12-23
FIBERLASE
FIBERLASE
73618737 not registered Dead/Abandoned
GENERAL FIBER OPTICS, INC.
1986-09-08
FIBERLASE
FIBERLASE
73403853 1300403 Dead/Cancelled
Barr & Stroud Limited
1982-11-23

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