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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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COMPACT TOUCH STS - 03700542625026

Ophthalmic Ultrasound Biomicroscope UBM and automatic STS measurement for ICL sizing The QUANTEL MEDICAL Compact Touch STS UBMTM Ophthalmic Ultrasound System (and its associated Linear 50 MHz probe) is intended to be used for diagnostic imaging and measurement of the eye including: • Visualization of the interior of the eye by B scans. • Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber depth).
QUANTEL MEDICAL
COMPACT TOUCH STS UBM
In Commercial Distribution

  • 03700542625026 ()


  • Ophthalmic ultrasound imaging system

COMPACT TOUCH - 03700542625019

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
In Commercial Distribution

  • 03700542625019 ()


  • Ophthalmic ultrasound imaging system

AVISO (S) - 03700542625002

AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound System The QUANTEL MEDICAL AVISO modular platform is an ultrasound system intended to be 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 (• 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
AVISO (S)
In Commercial Distribution

  • 03700542625002 ()


  • Ophthalmic ultrasound imaging system

SPIROWIN - 03760253450621

No Description
FIM MEDICAL
EXPERT DEPISTEO
In Commercial Distribution

  • 03760253450621 ()


  • Pulmonary function analysis system, adult

SPIROWIN - 03760253450614

No Description
FIM MEDICAL
Expert
In Commercial Distribution

  • 03760253450614 ()


  • Pulmonary function analysis system, adult

SPIROWIN - 03760253450607

No Description
FIM MEDICAL
EXPERT DEPISTEO
In Commercial Distribution

  • 03760253450607 ()


  • Pulmonary function analysis system, adult

QFLOW - 03760253450195

Single patient use spirometry sensor
FIM MEDICAL
QFLOW
In Commercial Distribution

  • 03760253450195 ()
  • 03760253450188 ()


  • Pulmonary function testing filter/mouthpiece

Spirowin - 03760253450010

No Description
FIM MEDICAL
Expert
Not in Commercial Distribution

  • 03760253450010 ()


  • Pulmonary function analysis system, adult

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

VEINOPLUS SPORT - 03701084900039

No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900039 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

VEINOPLUS DVT - 03701084900022

No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900022 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

VEINOPLUS - 03701084900015

No Description
AD REM TECHNOLOGY
2.1
In Commercial Distribution

  • 03701084900015 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

VEINOPLUS PACK - 03701084900008

No Description
AD REM TECHNOLOGY
8x13 OVAL
In Commercial Distribution

  • 03701084900008 ()


  • Transcutaneous electrical stimulation electrode, single-use

L18-5® - 03760193601527

Linear Probe L18-5®
Supersonic Imagine, Inc.
SSIP95100
In Commercial Distribution

  • 03760193601527 ()

  • Length: 250 Centimeter
SSIP95100

  • General-purpose ultrasound imaging system

C6-1X® - 03760193601411

Curved Probe C6-1X®
Supersonic Imagine, Inc.
SSIP95101
In Commercial Distribution

  • 03760193601411 ()

  • Length: 250 Centimeter
SSIP95101

  • General-purpose ultrasound imaging system
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