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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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Bolt Navigation - BN981BN001021

Bolt Navigation Unit, Gen 2.0
Circinus Medical Technology LLC
BN001-02
In Commercial Distribution

  • BN981BN001021 ()
BN001-02

  • Surgical planning/navigation-enhancement system

Bolt Navigation - B981BN00201103

Bolt Navigation Sterile Case used with the Bolt Navigation System
Circinus Medical Technology LLC
BN002-01-10
In Commercial Distribution

  • B981BN00201101 ()
  • B981BN00201103 ()
BN002-01-10

  • Surgical planning/navigation-enhancement system

Bolt Navigation - B981BN0010101

Bolt Navigation Unit
Circinus Medical Technology LLC
BN001-01-01
In Commercial Distribution

  • B981BN0010101 ()
BN001-01-01

  • Surgical planning/navigation-enhancement system

BEWELL CONNECT MyECG - 03760165449270

No Description
VISIOMED GROUP
BW-HR1
In Commercial Distribution

  • 03760165449270 ()


  • Cardiac mapping system

NA - 00841983104183

No Audio Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6804-7460
Not in Commercial Distribution

  • 00841983104183 ()
RNS-6804-7460

  • Centralized patient monitor

NA - 00841983104176

Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6803-7460
Not in Commercial Distribution

  • 00841983104176 ()
RNS-6803-7460

  • Centralized patient monitor

NA - 00841983103520

INTERACTIVE REMOTE CNS-6200
NIHON KOHDEN AMERICA, INC.
NK-CE770-CNS-S
In Commercial Distribution

  • 00841983103520 ()
NK-CE770-CNS-S

  • Centralized patient monitor

NA - 00841983103186

PATIENT MONITOR, with RECORDER
NIHON KOHDEN AMERICA, INC.
BSM-4104A
In Commercial Distribution

  • 00841983103186 ()
BSM-4104A

  • Centralized patient monitor

NA - 00841983102844

Additional alarm indicator unit, cable length
NIHON KOHDEN AMERICA, INC.
YS-098P1
In Commercial Distribution

  • 00841983102844 ()
YS-098P1

  • Centralized patient monitor

NA - 00841983102189

VL cable set (Second), cable length
NIHON KOHDEN AMERICA, INC.
YS-097P8
In Commercial Distribution

  • 00841983102189 ()
YS-097P8

  • Centralized patient monitor

NA - 00841983102165

VL cable set (Main), cable length
NIHON KOHDEN AMERICA, INC.
YS-097P5
In Commercial Distribution

  • 00841983102165 ()
YS-097P5

  • Centralized patient monitor

NA - 00841983101700

Alarm indicator, cable length
NIHON KOHDEN AMERICA, INC.
YL-612P
In Commercial Distribution

  • 00841983101700 ()
YL-612P

  • Centralized patient monitor

NA - 00841983101694

Alarm indicator, cable length
NIHON KOHDEN AMERICA, INC.
YL-611P
In Commercial Distribution

  • 00841983101694 ()
YL-611P

  • Centralized patient monitor

NA - 00841983101410

POWER SUPPLY KIT FOR WS-960P
NIHON KOHDEN AMERICA, INC.
SC-611R
In Commercial Distribution

  • 00841983101410 ()
SC-611RA

  • Centralized patient monitor

NA - 00841983103537

RNS STRIP RECORDER
NIHON KOHDEN AMERICA, INC.
WS-971R
In Commercial Distribution

  • 00841983103537 ()
WS-971R

  • Centralized patient monitor

NA - 00841983103513

INTERACTIVE RMT - DUAL CNS
NIHON KOHDEN AMERICA, INC.
NK-CE770CNS-D
In Commercial Distribution

  • 00841983103513 ()
NK-CE770CNS-D

  • Centralized patient monitor

NA - 00841983103193

PATIENT MONITOR, without RECORDER
NIHON KOHDEN AMERICA, INC.
BSM-4114A
In Commercial Distribution

  • 00841983103193 ()
BSM-4114A

  • Centralized patient monitor

NA - 00841983102851

Additional alarm indicator unit, cable length
NIHON KOHDEN AMERICA, INC.
YS-098P2
In Commercial Distribution

  • 00841983102851 ()
YS-098P2

  • Centralized patient monitor

NA - 00841983102196

VL cable set (Second), cable length
NIHON KOHDEN AMERICA, INC.
YS-097P9
In Commercial Distribution

  • 00841983102196 ()
YS-097P9

  • Centralized patient monitor

NA - 00841983102172

VL cable set (Main), cable length
NIHON KOHDEN AMERICA, INC.
YS-097P6
In Commercial Distribution

  • 00841983102172 ()
YS-097P6

  • Centralized patient monitor
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