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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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DEPTHALON® - 00650551096023

MICROWIRE DEPTHALON ELECTRODE, 10 MICROWIRE CONTACTS, INLINE TAILS WITH 10CM LEADS
PMT CORPORATION
2104-12-10-001-NS
In Commercial Distribution

  • 00650551096023 ()

  • Main Tube Length 20 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-12-10-001-NS

  • Depth electrode

DEPTHALON® - 00650551096016

MICROWIRE DEPTHALON ELECTRODE, 14 MICROWIRE CONTACTS, INLINE CONNECTOR WITH 10CM LEAD
PMT CORPORATION
2104-10-14-001-NS
In Commercial Distribution

  • 00650551096016 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 24 Centimeter
2104-10-14-001-NS

  • Depth electrode

DEPTHALON® - 00650551096009

MICROWIRE DEPTHALON ELECTRODE, 4 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-10-04-003-NS
In Commercial Distribution

  • 00650551096009 ()

  • Main Tube Length 22 Centimeter
  • Microwire Diameter 75 Micrometer
  • Contact Size 2 Millimeter
2104-10-04-003-NS

  • Depth electrode

DEPTHALON® - 00650551095996

MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-08-16-001-NS
In Commercial Distribution

  • 00650551095996 ()

  • Contact Size 1.4 Millimeter
  • Microwire Diameter 40 Micrometer
2104-08-16-001-NS

  • Depth electrode

DEPTHALON® - 00650551095989

MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-08-08-003-NS
In Commercial Distribution

  • 00650551095989 ()

  • Main Tube Length 32 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-08-08-003-NS

  • Depth electrode

DEPTHALON® - 00650551095972

MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-08-08-002-NS
In Commercial Distribution

  • 00650551095972 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 32 Centimeter
2104-08-08-002-NS

  • Depth electrode

DEPTHALON® - 00650551095965

MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS WITH 10CM LEAD
PMT CORPORATION
2104-04-16-03-104-NS
In Commercial Distribution

  • 00650551095965 ()

  • Main Tube Length 30 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-04-16-03-104-NS

  • Depth electrode

DEPTHALON® - 00650551095958

MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS WITH 10CM LEAD
PMT CORPORATION
2104-04-16-03-103-NS
In Commercial Distribution

  • 00650551095958 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
2104-04-16-03-103-NS

  • Depth electrode

DEPTHALON® - 00650551095941

MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-03-102-NS
In Commercial Distribution

  • 00650551095941 ()

  • Main Tube Length 30 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-04-16-03-102-NS

  • Depth electrode

DEPTHALON® - 00650551095934

MICROWIRE DEPTHALON ELECTRODE, 32 MICROWIRE CONTACTS, 3 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-02-053-NS
In Commercial Distribution

  • 00650551095934 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
  • Contact Size 2 Millimeter
2104-04-16-02-053-NS

  • Depth electrode

DEPTHALON® - 00650551095927

MICROWIRE DEPTHALON ELECTRODE, 32 MICROWIRE CONTACTS, 3 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-02-052-NS
In Commercial Distribution

  • 00650551095927 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
2104-04-16-02-052-NS

  • Depth electrode

DEPTHALON® - 00650551095910

MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-00-08-009-NS
In Commercial Distribution

  • 00650551095910 ()

  • Main Tube Length 15 Centimeter
  • Microwire Diameter 25 Micrometer
2104-00-08-009-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092988

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-07-NS
In Commercial Distribution

  • 00650551092988 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.03125 Inch
2102-32-07-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092971

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-06-NS
In Commercial Distribution

  • 00650551092971 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-06-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092940

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-01-NS
In Commercial Distribution

  • 10650551092947 ()
  • 00650551092940 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-01-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092926

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2102-31-01-NS
In Commercial Distribution

  • 10650551092923 ()
  • 00650551092926 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-31-01-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092902

STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-01-NS
In Commercial Distribution

  • 10650551092909 ()
  • 00650551092902 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-01-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092889

STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2101-31-01-NS
In Commercial Distribution

  • 10650551092886 ()
  • 00650551092889 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-31-01-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 00650551092797

CRIMPING TOOL FOR NON-CRIMPED SPHENOIDAL ELECTRODE
PMT CORPORATION
2105
In Commercial Distribution

  • 00650551092797 ()
2105

  • Depth electrode

LEXO - 09120077180076

The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.
tyromotion GmbH
R1
In Commercial Distribution

  • 09120077180076 ()


  • Treadmill/elliptical gait rehabilitation system

THERA-Trainer lyra - 04041925002775

The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.
medica - Medizintechnik GmbH
01.XX.XX
In Commercial Distribution

  • 04041925002775 ()


  • Treadmill/elliptical gait rehabilitation system

Activator - 08625630003010

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump

Activator - 08625630003001

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump

QuantumCam - 05711665003033

Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003033 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system

BodyMD - 05711665003026

Gamma Camera System
Ddd-Diagnostic A/S
BodyMD Gamma Camera System
Not in Commercial Distribution

  • 05711665003026 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system

BodyMD - 05711665003019

Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003019 ()

  • Width: 291 Centimeter
  • Depth: 197 Centimeter
  • Height: 225 Centimeter
  • Weight: 2144 Kilogram
9PMS3131

  • Stationary gamma camera system

QuantumCam - 05711665003002

Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution

  • 05711665003002 ()

  • Weight: 2144 Kilogram
  • Height: 225 Centimeter
  • Depth: 197 Centimeter
  • Width: 291 Centimeter
9SYS2070

  • Stationary gamma camera system

CardioMD - 05711665002029

Gamma Camera System
Ddd-Diagnostic A/S
CardioMD Gamma Camera System
Not in Commercial Distribution

  • 05711665002029 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system

CardioMD - 05711665002012

Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002012 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system

CorCam - 05711665002005

Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002005 ()

  • Weight: 815 Kilogram
  • Height: 150 Centimeter
  • Depth: 150 Centimeter
  • Width: 284 Centimeter
9COR2370

  • Stationary gamma camera system

C.Cam - 05711665001008

Gamma Camera System
Ddd-Diagnostic A/S
c.cam Gamma Camera System
In Commercial Distribution

  • 05711665001008 ()

  • Weight: 1350 Kilogram
  • Height: 169 Centimeter
  • Depth: 229 Centimeter
  • Width: 244 Centimeter
9VIR1200

  • Stationary gamma camera system

Magnetic Shield - 00862563003191

Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003191 ()
403350

  • Intraurethral valve/pump

Activator Kit - 00862563003184

Magnetic remote control for the inFlow Device - with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003184 ()
403507K

  • Intraurethral valve/pump

Medical Charger - 00862563003177

Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003177 ()
403320

  • Intraurethral valve/pump

Base Station - 00862563003160

Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump

Activator - 00862563003153

Magnetic remote control for the inFlow Device
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003153 ()
403300

  • Intraurethral valve/pump

NM - 00195278788252

830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00195278788252 ()
5376204-33

  • Stationary gamma camera system

MyoSEPCT ES to MyoSPECT Upgrade - 00195278722546

MyoSPECT ES to MyoSPECT Upgrade kit
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BS
In Commercial Distribution

  • 00195278722546 ()
5941445

  • Stationary gamma camera system

MyoSPECT ES - 00195278488626

MyoSPECT ES MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BD
In Commercial Distribution

  • 00195278488626 ()
5875815-40

  • Stationary gamma camera system

MyoSPECT - 00195278488619

MyoSPECT MDR GANTRY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3912BC
In Commercial Distribution

  • 00195278488619 ()
5875815-30

  • Stationary gamma camera system
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