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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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Spirolyser - 03760253450003

No Description
FIM MEDICAL
Q13
In Commercial Distribution

  • 03760253450003 ()


  • Pulmonary function analysis system, adult

RespIn - 03760251321107

RespIn 11 Bronchial Airway Clearance System is a "Focused Pulse" High Frequency Chest Wall Oscillation (HFCWO) device that maximizes the use of modern technologies and materials to produce a more comfortable, flexible and effective therapy delivery system.
RESPINNOVATION
11
In Commercial Distribution

  • 03760251321107 ()


  • Chest-oscillation airway secretion-clearing system

EXPASYL x6 - 03760243005008

Sulcular opening paste (x6 capsules).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243007033 ()
  • 03760243005008 ()
  • 03760243009808 ()
294010

  • Gingival retraction kit

Classic by RISKONTROL - 03760243001093

Disposable single use tips for air/water syringe (dental).
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009907 ()
  • 03760243001093 ()
201669

  • Surgical mist irrigation tip

ACTEON - 03760243001048

Expasyl is a paste for temporary gingival retraction that ensures separation of the marginal gingiva and drying of the sulcus
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL EXACT
In Commercial Distribution

  • 03760243001048 ()
  • 03760243007170 ()
  • 03760243007187 ()
  • 03760243007194 ()


  • Gingival retraction kit

ACTEON - 03760243000959

HEMOSTASYL is a paste to be used as a haemostatic dressing with a mechanical action. Kit containing: 2 x 2g syringes of HEMOSTASYL Paste (about 30 uses) and 40 HEMOSTASYL angled application cannulas. Syringe for multiple uses. Application cannulas for single use.
PRODUITS DENTAIRES PIERRE ROLLAN
Hemostasyl Kit
Not in Commercial Distribution

  • 03760243000959 ()
246200

  • Non-organic haemostatic agent

ACTEON - 03760243000942

box with 40 angled application cannulas for Hemostasyl paste in syringe
PRODUITS DENTAIRES PIERRE ROLLAN
Hemostasyl canula
Not in Commercial Distribution

  • 03760243000942 ()
246100

  • Dental material injection cannula, single-use

ACTEON - 03760243000935

HEMOSTASYL is an original paste to be used as a haemostatic dressing with a mechanical action. Box with 2 x 2g multiple use syringes of HEMOSTASYL paste
PRODUITS DENTAIRES PIERRE ROLLAN
Hemostasyl syringes
Not in Commercial Distribution

  • 03760243000935 ()
  • 03760243007125 ()
246050

  • Non-organic haemostatic agent

EXPASYL - 03760243000775

6 capsules (sulcular opening paste) + 1 applicator + 12 application cannulas.
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243000775 ()
294100

  • Gingival retraction kit

Expasyl cannulas - 03760243000751

Expasyl bended application cannulas x100 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009839 ()
  • 03760243000751 ()
261015

  • Dental material injection cannula, single-use

Expasyl cannulas - 03760243000744

Expasyl bended application cannulas x40 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009839 ()
  • 03760243000744 ()
261045

  • Dental material injection cannula, single-use

Expasyl cannulas - 03760243000737

Expasyl straight application cannulas x100 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009822 ()
  • 03760243000737 ()
261005

  • Dental material injection cannula, single-use

Expasyl cannulas - 03760243000720

Expasyl straight application cannulas x40 for EXPASYL paste (sulcular opening paste).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009822 ()
  • 03760243000720 ()
261040

  • Dental material injection cannula, single-use

EXPASYL strawberry flavor - 03760243000713

Sulcular opening paste (x20 capsules).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243007040 ()
  • 03760243000713 ()
  • 03760243009815 ()
261001

  • Gingival retraction kit

EXPASYL x20 - 03760243000706

Sulcular opening paste (x20 capsules).
PRODUITS DENTAIRES PIERRE ROLLAN
EXPASYL
In Commercial Distribution

  • 03760243009808 ()
  • 03760243000706 ()
  • 03760243007026 ()
261030

  • Gingival retraction kit

Total protec by RISKONTROL - 03760243000553

Disposable single use tips with sheath for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243000553 ()
  • 03760243009976 ()
201751

  • Surgical mist irrigation tip

Total protec by RISKONTROL - 03760243000546

Disposable single use tips with sheath for air/water syringe.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009969 ()
  • 03760243000546 ()
201750

  • Surgical mist irrigation tip

Classic by RISKONTROL - 03760243000539

Disposable single use tips for air/water syringe.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009952 ()
  • 03760243000539 ()
201668

  • Surgical mist irrigation tip

Classic by RISKONTROL - 03760243000522

Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009945 ()
  • 03760243000522 ()
201667

  • Surgical mist irrigation tip

Classic by RISKONTROL - 03760243000515

Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009938 ()
  • 03760243000515 ()
201666

  • Surgical mist irrigation tip

Classic by RISKONTROL - 03760243000508

Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009921 ()
  • 03760243000508 ()
201665

  • Surgical mist irrigation tip

Classic by RISKONTROL - 03760243000492

Disposable single use tips for air/water syringe
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009914 ()
  • 03760243000492 ()
201664

  • Surgical mist irrigation tip

Art by RISKONTROL - 03760243000430

Disposable single use tips for air/water syringe.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243009853 ()
  • 03760243000430 ()
201700

  • Surgical mist irrigation tip

ADAPTATER RISKONTROL LU NEW INOX - 03760243000270

The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243000270 ()
200199

  • Dental delivery system irrigation handpiece

ADAPTATER RISKONTROL LU INOX - 03760243000263

The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243000263 ()
200150

  • Dental delivery system irrigation handpiece

ADAPTATER RISKONTROL DCI - 03760243000089

The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
PRODUITS DENTAIRES PIERRE ROLLAN
RISKONTROL
In Commercial Distribution

  • 03760243000089 ()
200152

  • Dental delivery system irrigation handpiece

IBC-Lite - 08719324589024

Dose Calibrator Read Out Unit
Comecer Netherlands B.V.
0203010016
In Commercial Distribution

  • 08719324589024 ()


  • Radioisotope calibration system

VIK202 - 08719324589000

Measuring unit for the dose calibrator
Comecer Netherlands B.V.
0202020001
In Commercial Distribution

  • 08719324589000 ()


  • Radioisotope calibration system

AXIALIS - 03700542625941

The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
AXIALIS
In Commercial Distribution

  • 03700542625941 ()


  • Ophthalmic ultrasound imaging system

EASYRET - 03700542625927

The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator device intended for the treatment of retinal diseases.
QUANTEL MEDICAL
EASYRET
In Commercial Distribution

  • 03700542625927 ()


  • Ophthalmic solid-state laser system

VITRA 810 - 03700542625613

The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the retinal diseases and glaucoma.
QUANTEL MEDICAL
VITRA 810
In Commercial Distribution

  • 03700542625613 ()


  • Ophthalmic solid-state laser system

VITRA 2 - 03700542625569

The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye.
QUANTEL MEDICAL
VITRA 2
In Commercial Distribution

  • 03700542625569 ()


  • Ophthalmic solid-state laser system

COMPACT TOUCH - 03700542625545

Ophthalmic Ultrasound System: A/B Scan and Pachymetry The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
COMPACT TOUCH 2017
In Commercial Distribution

  • 03700542625545 ()


  • Ophthalmic ultrasound imaging system

B Probe 15MHz COMPACT TOUCH - 03700542625538

15 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma.
QUANTEL MEDICAL
B1 COMPACT TOUCH 2017
In Commercial Distribution

  • 03700542625538 ()


  • Ophthalmic ultrasound imaging transducer

ABSOLU - 03700542625521

The ABSolu is a high definition multifunction ophthalmic ultrasound system used for: - Axial Length measurement of the eye by ultrasonic means; - Implanted IOL power calculation, using the axial length measurement; - Visualization of the interior of the eye and the orbit by A and B scans. - ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.
QUANTEL MEDICAL
ABSOLU
In Commercial Distribution

  • 03700542625521 ()


  • Ophthalmic ultrasound imaging system

EASYRET - 03700542625484

The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Haag Streit mode) is a photocoagulator device intended for the treatment of retinal diseases.
QUANTEL MEDICAL
EASYRET
In Commercial Distribution

  • 03700542625484 ()


  • Ophthalmic solid-state laser system

OPTIMIS FUSION - 03700542625460

SLT/YAG Laser (Dual-mode laser cavity, 532nm and 1064nm)
QUANTEL MEDICAL
OPTIMIS FUSION
In Commercial Distribution

  • 03700542625460 ()


  • Ophthalmic solid-state laser system, photodisruption

SOLUTIS - 03700542625453

Adaptable SLT Laser (Selective Trabeculoplasty - 532nm)
QUANTEL MEDICAL
SLT
In Commercial Distribution

  • 03700542625453 ()


  • Ophthalmic solid-state laser system, photodisruption

532nm VITRA MULTISPOT adaptor for OPTIMIS FUSION coupling - 03700542625446

No Description
QUANTEL MEDICAL
VMSSC532FUS
In Commercial Distribution

  • 03700542625446 ()
1

  • Laser adaptor

532nm VITRA MULTISPOT adaptor for OPTIMIS II coupling - 03700542625439

No Description
QUANTEL MEDICAL
VMSSC532OPT
In Commercial Distribution

  • 03700542625439 ()


  • Laser adaptor

532nm VITRA MULTISPOT adaptor - 03700542625422

No Description
QUANTEL MEDICAL
VMSSC532
In Commercial Distribution

  • 03700542625422 ()


  • Laser adaptor

VITRA MULTISPOT - 03700542625415

532nm Multispot Laser Retinal Photocoagulation
QUANTEL MEDICAL
VMS
In Commercial Distribution

  • 03700542625415 ()


  • Ophthalmic solid-state laser system

577nm adaptor for Keeler Vantage Plus IO (100µ) - 03700542625408

577nm adaptor for Keeler Vantage Plus Indirect Ophthalmoscope (100µ)
QUANTEL MEDICAL
577IOV100
In Commercial Distribution

  • 03700542625408 ()


  • Indirect binocular laser ophthalmoscope

577nm Heine Omega 500 IO with integrated adaptor - 03700542625392

577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor
QUANTEL MEDICAL
IOH577
In Commercial Distribution

  • 03700542625392 ()


  • Indirect binocular laser ophthalmoscope

577nm adaptor for ZEISS 130 Slit Lamp - 03700542625385

No Description
QUANTEL MEDICAL
577CZ130ST
In Commercial Distribution

  • 03700542625385 ()


  • Laser adaptor

577nm adaptor for ZEISS 120 Slit Lamp - 03700542625378

No Description
QUANTEL MEDICAL
577CZ120ST
In Commercial Distribution

  • 03700542625378 ()


  • Laser adaptor

577nm adaptor for ZEISS 30 Slit Lamp - 03700542625361

No Description
QUANTEL MEDICAL
577CZ30ST
In Commercial Distribution

  • 03700542625361 ()


  • Laser adaptor

577nm adaptor for HS900 BM/BQ Slit Lamp - 03700542625354

Fold away 577nm adaptor for HS900 BM/BQ Slit Lamp (Single Spot)
QUANTEL MEDICAL
577HSD
In Commercial Distribution

  • 03700542625354 ()


  • Laser adaptor

577nm adaptor for OPTIMIS II - 03700542625347

577nm adaptor for OPTIMIS II (Single Spot)
QUANTEL MEDICAL
577OPT2STD
In Commercial Distribution

  • 03700542625347 ()


  • Laser adaptor

SUPRASCAN 577nm for OPTIMIS II - 03700542625330

SUPRASCAN 577nm adaptor for OPTIMIS II (MultiSpot)
QUANTEL MEDICAL
SUPSC577OPT
In Commercial Distribution

  • 03700542625330 ()


  • Laser adaptor
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