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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ELITA - 05050474738553

ELITA FEMTOSECOND LASER
JOHNSON & JOHNSON SURGICAL VISION, INC.
EL2022
In Commercial Distribution

  • 05050474738553 ()
0155-1001

  • Femtosecond ophthalmic solid-state laser system

CATALYS SYSTEM - 05050474709508

CATALYS ELEVATED SYS ACCY,USE W/MPB,US
OPTIMEDICA CORPORATION
0160-9500
In Commercial Distribution

  • 05050474709508 ()
0160-9500

  • Femtosecond ophthalmic solid-state laser system

FS LASER SYSTEM - 05050474573451

FS LASER SYS M2, IEK CAP, 120V, 60HZ
JOHNSON & JOHNSON SURGICAL VISION, INC.
20005D
In Commercial Distribution

  • 05050474573451 ()
20005D

  • Femtosecond ophthalmic solid-state laser system

CATALYS PATIENT CHAIR - 05050474617193

PATIENT CHAIR
JOHNSON & JOHNSON SURGICAL VISION, INC.
0160-6030
In Commercial Distribution

  • 05050474617193 ()
0160-6030

  • Femtosecond ophthalmic solid-state laser system

CATALYS SYSTEM - 05050474617186

CATALYS SYSTEM, US, NO BED
JOHNSON & JOHNSON SURGICAL VISION, INC.
Catalys Precision Laser System
In Commercial Distribution

  • 05050474617186 ()
0160-6020

  • Femtosecond ophthalmic solid-state laser system

CATALYS SYSTEM - 05050474609792

CATALYS SYSTEM, US
OPTIMEDICA CORPORATION
CATALYS-U
In Commercial Distribution

  • 05050474609792 ()
CATALYS-U

  • Femtosecond ophthalmic solid-state laser system

IFS ADVANCED FEMTOSEC LASER - 05050474573468

IFS ADV FS LASER SYSTEM, 120V, 60HZ
JOHNSON & JOHNSON SURGICAL VISION, INC.
J20007D
In Commercial Distribution

  • 05050474573468 ()
J20007D

  • Femtosecond ophthalmic solid-state laser system

BioJet Target - 04260476810015

Software for biopsy needle guide planning and tracking.
Medical Targeting Technologies GmbH
3
In Commercial Distribution

  • 04260476810015 ()


  • Brachytherapy system application software

QScreen Set - 04260223147302

Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 100306 Headphone DD45 HP-06 or 101044 Headphone DD-65 v2 P/N 101315-E QScreen Check Kit P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100465-QScreen FW ASSR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english
PATH medical GmbH
101275-AS-HP
In Commercial Distribution

  • 04260223147302 ()


  • Evoked-potential audiometer

QScreen Set - 04260223147296

Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 100860 Insert earphone PATH P/N 101315-E QScreen Check Kit P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100465-QScreen FW ASSR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english
PATH medical GmbH
101275-AS-IP
In Commercial Distribution

  • 04260223147296 ()


  • Evoked-potential audiometer
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