Twister™ Side-Fire Fiber Optic Delivery System 101315

GUDID 04049089300225

Ceram Optec SIA

Urogenital surgical laser system beam guide, single-use
Primary Device ID04049089300225
NIH Device Record Key3bd9c6d7-4582-4a6c-819e-2c4fd8b8ef93
Commercial Distribution StatusIn Commercial Distribution
Brand NameTwister™ Side-Fire Fiber Optic Delivery System
Version Model NumberTwister™ XXL
Catalog Number101315
Company DUNS506069240
Company NameCeram Optec SIA
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104049089100221 [Primary]
GS104049089200228 [Package]
Contains: 04049089100221
Package: Box [1 Units]
In Commercial Distribution
GS104049089300225 [Package]
Contains: 04049089200228
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-03-09

On-Brand Devices [Twister™ Side-Fire Fiber Optic Delivery System]

04049089300225Twister™ XXL
04049089300201Twister™ XL
04049089300188Twister™ L
04049089300164Twister™ Slim
04049089300140Twister™

Trademark Results [Twister]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TWISTER
TWISTER
98419019 not registered Live/Pending
Gates Corporation
2024-02-23
TWISTER
TWISTER
98075782 not registered Live/Pending
QUANTUM-SYSTEMS INC.
2023-07-07
TWISTER
TWISTER
98027932 not registered Live/Pending
Colgate-Palmolive Company
2023-06-05
TWISTER
TWISTER
97800847 not registered Live/Pending
Martinez, Michael A
2023-02-17
TWISTER
TWISTER
97587505 not registered Live/Pending
Zulay LLC
2022-09-12
TWISTER
TWISTER
97553364 not registered Live/Pending
Algood Casters Limited
2022-08-17
TWISTER
TWISTER
97526403 not registered Live/Pending
Webster Combustion Technology LLC
2022-07-29
TWISTER
TWISTER
97498657 not registered Live/Pending
Central Ozark Machine, Inc.
2022-07-12
TWISTER
TWISTER
97186572 not registered Live/Pending
Fong Prean Industrial Co., Ltd.
2021-12-23
TWISTER
TWISTER
90891792 not registered Live/Pending
Horizons International Corp.
2021-08-19
TWISTER
TWISTER
90324970 not registered Live/Pending
M & F Western Products, Inc.
2020-11-17
TWISTER
TWISTER
90321580 not registered Live/Pending
Yetter Manufacturing, Inc.
2020-11-16

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