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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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PANTA® - 10381780051466

The trocar awl is used to prepare the bone for drilling.
NEWDEAL
519040ND
In Commercial Distribution

  • M248519040ND1 ()
  • 10381780051466 ()

  • 4.3mm diameter X 200mm total length


  • Bone awl, reusable

iProven - 08719699633469

BPM-337 ables to measure the blood pressure and the heart rate
Sevenground Trading B.V.
BPM-337
In Commercial Distribution

  • 08719699633469 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

iProvèn - 08719699636507

BPM-617 ables to measure the blood pressure and the heart rate
Sevenground Trading B.V.
BPM-617
In Commercial Distribution

  • 08719699636507 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

iProvèn - 08719699636491

BPM-417 ables to measure the blood pressure and the heart rate
Sevenground Trading B.V.
BPM-417
In Commercial Distribution

  • 08719699636491 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

iProven - 08719699630451

BPM-337BLU ables to measure the blood pressure and the heart rate
Sevenground Trading B.V.
BPM-337BLU
In Commercial Distribution

  • 08719699630451 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Orthovisc - 05060604130010

Inject into the knee to relieve the pain caused by osteoarthritis.
ACRE PHARMA LIMITED
NA
In Commercial Distribution

  • 05060604130010 ()


  • Synovial fluid supplementation medium

Dongle Assembly - 05065012584233

Allow connection of the single use sensor to the Panel PC.
EVENTUM ORTHOPAEDICS LTD
CA001
In Commercial Distribution

  • 05065012584233 ()


  • Electrical-only medical device connection cable, reusable

Aria Valve AK Valve Key - 00850013242702

Tool used to remove or install the valve in the socket
CYPRESS ADAPTIVE, LLC
CA100-K
In Commercial Distribution

  • 00850013242702 ()
CA100-K

  • External lower-limb prosthesis suspensory component, non-powered

Awl 7mm & 8mm - 08437019739515

Used to insert the screw of the WasherCap™ Fixation System.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739515 ()
  • 28437019739519 ()


  • Bone awl, reusable

Awl 9mm & 10mm - 08437019739539

Used to insert the screw of the WasherCap™ Fixation System.
ABANZA TECNOMED SL.
21
In Commercial Distribution

  • 08437019739539 ()
  • 28437019739533 ()


  • Bone awl, reusable

Paxman Accessories - B561ACCESSORIES2

Accessory items used to support the use of the PSCS device.
PAXMAN COOLERS LIMITED
Accessories Pack
Not in Commercial Distribution

  • B561ACCESSORIES2 ()
Accessories Pack

  • Scalp cooling system, hair loss

Compower - 06946430423320

Headgear is designed to fit the mask over the patient's head.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
CP611001
In Commercial Distribution

  • 16946430423327 ()
  • 06946430423320 ()


  • Anaesthesia mask strap, single-use

iSyncWave - 08800108500363

iSyncWaveTM is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWaveTM measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWaveTM App. The data is displayed and recorded via the iSyncWaveTM App. iSyncWaveTM uses dry electrode technology, which doesn’t require a preparation process(e.g., applying conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWaveTM app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWaveTM app. iSyncWaveTM can be only used by professional and/or medical personnel with product training and experience in EEG measurement. The professional and/or medical personnel can check the signal quality in real time and refer to the measured data in clinical practice.
iMediSync, Inc.
ISW-MUS101
In Commercial Distribution

  • 08800108500363 ()


  • Electroencephalograph

TITAN™ - 10381780258599

The Fin-Lock Sizer is used to measure the size of the glenoid and mark the center of the glenoid.
Ascension Orthopedics, Inc.
SZR-0926-030-030
In Commercial Distribution

  • M269SZR09260300301 ()
  • 10381780258599 ()

  • Large


  • Surgical implant template, reusable

TITAN™ - 10381780258568

The Fin-Lock Sizer is used to measure the size of the glenoid and mark the center of the glenoid.
Ascension Orthopedics, Inc.
SZR-0926-030-020
In Commercial Distribution

  • M269SZR09260300201 ()
  • 10381780258568 ()

  • Medium


  • Surgical implant template, reusable

TITAN™ - 10381780258537

The Fin-Lock Sizer is used to measure the size of the glenoid and mark the center of the glenoid.
Ascension Orthopedics, Inc.
SZR-0926-030-010
In Commercial Distribution

  • M269SZR09260300101 ()
  • 10381780258537 ()

  • Small


  • Surgical implant template, reusable

TITAN™ - 10381780258506

The Fin-Lock Sizer is used to measure the size of the glenoid and mark the center of the glenoid.
Ascension Orthopedics, Inc.
SZR-0926-030-000
In Commercial Distribution

  • M269SZR09260300001 ()
  • 10381780258506 ()

  • X-Small


  • Surgical implant template, reusable

ORA Retaining Cap - 00841549115776

The retaining cap engages the outside of the ball shape and allows retention of the prosthesis to the denture.
STERNGOLD DENTAL LLC
904064
In Commercial Distribution

  • 00841549115776 ()


  • Resilient dental precision attachment

Attachable delivery unit (30SL/M) - 04987669100875

The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system that ensures low laser power density on the anterior segment is incorporated. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system. The ZEISS 30 SL type is availabe.
NIDEK CO.,LTD.
17431-0000
In Commercial Distribution

  • 04987669100875 ()


  • General/multiple surgical frequency-doubled solid-state laser system

TITAN™ - 10381780258353

The Fin-Lock Punch is used to impact the bone for proper fit of the glenoid. It can also be used to further pressurize the cement.
Ascension Orthopedics, Inc.
PN-0926-001
In Commercial Distribution

  • M269PN09260011 ()
  • 10381780258353 ()

  • 8.0 in L x 1.5 in end diameter


  • Bone cutter

SURFIX® - 10381780052036

The SURFIX® plate bender is used to bend the SURFIX® osteosynthesis plates to fit the bone configuration without damaging the threaded lipped sockets.
NEWDEAL
MA003ND
In Commercial Distribution

  • M248MA003ND1 ()
  • 10381780052036 ()


  • Manual orthopaedic bender, reusable

Pen Tracker - 03770022347144

The pen is used in order to collect positioning of reference points in space. The pen is used to calibrate the precision of the device.
MODJAW
TALLY
In Commercial Distribution

  • 03770022347144 ()
Pen Tracker

  • Jaw physiology evaluation system

KINVENT - 03770011995554

Sens is an inertial sensor to measure the range of motion and to compare the symmetry between the injured limb’s amplitude and the healthy limb.
KINVENT HELLAS
Sens V2R01
In Commercial Distribution

  • 03770011995554 ()


  • Electronic goniometer/kinesiology sensor

Global Reference Module 16 - 00850011306666

The Global Reference Module 16 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 16
In Commercial Distribution

  • 00850011306666 ()
31-0604-0058

  • Electroencephalographic signal amplifier

Global Reference Module 15 - 00850011306659

The Global Reference Module 15 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 15
In Commercial Distribution

  • 00850011306659 ()
31-0604-0057

  • Electroencephalographic signal amplifier

Global Reference Module 14 - 00850011306642

The Global Reference Module 14 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 14
In Commercial Distribution

  • 00850011306642 ()
31-0604-0056

  • Electroencephalographic signal amplifier

Global Reference Module 13 - 00850011306635

The Global Reference Module 13 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 13
In Commercial Distribution

  • 00850011306635 ()
31-0604-0055

  • Electroencephalographic signal amplifier

Global Reference Module 12 - 00850011306628

The Global Reference Module 12 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 12
In Commercial Distribution

  • 00850011306628 ()
31-0604-0054

  • Electroencephalographic signal amplifier

Global Reference Module 11 - 00850011306611

The Global Reference Module 11 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 11
In Commercial Distribution

  • 00850011306611 ()
31-0604-0053

  • Electroencephalographic signal amplifier

Global Reference Module 10 - 00850011306604

The Global Reference Module 10 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 10
In Commercial Distribution

  • 00850011306604 ()
31-0604-0052

  • Electroencephalographic signal amplifier

Global Reference Module 9 - 00850011306598

The Global Reference Module 9 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 9
In Commercial Distribution

  • 00850011306598 ()
31-0604-0051

  • Electroencephalographic signal amplifier

Global Reference Module 8 - 00850011306581

The Global Reference Module 8 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 8
In Commercial Distribution

  • 00850011306581 ()
31-0604-0050

  • Electroencephalographic signal amplifier

Global Reference Module 7 - 00850011306574

The Global Reference Module 7 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 7
In Commercial Distribution

  • 00850011306574 ()
31-0604-0049

  • Electroencephalographic signal amplifier

Global Reference Module 6 - 00850011306567

The Global Reference Module 6 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 6
In Commercial Distribution

  • 00850011306567 ()
31-0604-0048

  • Electroencephalographic signal amplifier

Global Reference Module 5 - 00850011306550

The Global Reference Module 5 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 5
In Commercial Distribution

  • 00850011306550 ()
31-0604-0047

  • Electroencephalographic signal amplifier

Global Reference Module 4 - 00850011306543

The Global Reference Module 4 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 4
In Commercial Distribution

  • 00850011306543 ()
31-0604-0046

  • Electroencephalographic signal amplifier

Global Reference Module 3 - 00850011306536

The Global Reference Module 3 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 3
In Commercial Distribution

  • 00850011306536 ()
31-0604-0045

  • Electroencephalographic signal amplifier

Global Reference Module 2 - 00850011306529

The Global Reference Module 2 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 2
In Commercial Distribution

  • 00850011306529 ()
31-0604-0044

  • Electroencephalographic signal amplifier

canturio™te Cemented Tibia Drill Bit - 00850015699009

The Canary Medical Drill Bit is used to create the cavity in the patient’s tibial intramedullary canal to fit the CTE implant and cement mantle.
Canary Medical USA LLC
43-5399-058-14
In Commercial Distribution

  • 00850015699009 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Lansinoh Smart Pump Base Only - 00044677531498

The powered breast pump is intended to express and collect the breast milkof a nursing womanfor the purpose of feeding the collected milk to baby
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
DEBP 2.2
In Commercial Distribution

  • 00044677531498 ()
P53149-01

  • Breast pump, electric
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