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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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SpO2.COM® adult/neonatal SpO2 disposable sensor - 10843997000496

No Description
MASIMO CORPORATION
1776
In Commercial Distribution

  • 10843997000496 ()
  • 00843997000499 ()


  • Pulse oximeter probe, single-use

SpO2.COM™ SpO2 disposable sensor sample pack - 10843997010358

No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use

SpO2.COM® RS-1 adult SpO2 reusable sensor - 00843997000505

No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable

BIOMET - 00815634020283

RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1
Micromedics, Inc.
800-0217
In Commercial Distribution

  • 00815634020283 ()
  • 10815634020280 ()
  • 20815634020287 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

STERILE ROBOT ARM INTERFACE - 03760244030436

Robot Arm Interface instrument Rosa 3.0 instrument ROSA One spine app 3.1
MEDTECH
ROSA3-048A
Not in Commercial Distribution

  • 03760244030436 ()
ROSAS00126

  • Neurological stereotactic surgery system
  • Multi-purpose stereotactic surgery system

OvuSense - 05060508530039

M300 OvuCore Starter Pack - M026 OvuCore Vaginal Sensor and M032 OvuSense App
VIO HEALTHTECH LIMITED
M300
In Commercial Distribution

  • 05060508530039 ()


  • Thermometric fertility analyser

iProvèn - 08719481720193

Ear thermometer with bluetooth which transmits data to app on mobile phone
Masena Invest B.V.
ET-624BT
In Commercial Distribution

  • 08719481720193 ()


  • Intermittent electronic patient thermometer

DRIVEMEDICAL - 00822383103747

Pressure PreventionGroup 1 Surfaces Product Description: APP Pad Only, 1/ea, RTL
Drive Devilbiss Healthcare
14003
In Commercial Distribution

  • 50822383103742 ()
  • 00822383103747 ()


  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure bed mattress overlay system

Orpheus CAST Mobile App Android OS - 07290017025124

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software

Orpheus CAST Mobile App iOS + Android - 07290017025100

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software

Resilience – By Inner Armor App iOS - 07540191000630

No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system

.decimal Astroid Planning App 3.x - 00851147007120

The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software

Eversense® NOW Mobile App iOS - 00817491021267

Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system

Biotem - 08800036204173

Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 4.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4846C
In Commercial Distribution

  • 08800036204173 ()


  • Dental implant system

Biotem - 08800036204166

Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 2.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4826C
In Commercial Distribution

  • 08800036204166 ()


  • Dental implant system

Diamondback Peripheral - 10852528005992

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL200
In Commercial Distribution

  • 10852528005992 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.50mm
7-10031-08

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005985

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL200
In Commercial Distribution

  • 10852528005985 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.25mm
7-10031-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005978

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid 75 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL75
In Commercial Distribution

  • 10852528005978 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75cm
  • Nose Length: 7mm
  • Crown diameter: 1.25mm
7-10031-06

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005909

Diamondback Peripheral, Exchangeable Series, 1.50 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-150CLA145
In Commercial Distribution

  • 10852528005909 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 15 mm
  • Crown Diameter: 1.50 mm
7-10030-10

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005893

Diamondback Peripheral, Exchangeable Series, 1.75 Solid, 180 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-175SOL180
In Commercial Distribution

  • 10852528005893 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length:180 cm
  • Nose Length: 30 mm
  • Crown Diameter: 1.75 mm
7-10030-09

  • Mechanical atherectomy system catheter, peripheral
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