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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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532-577nm adaptor for ZEISS microscope - 03700542625255

532-577nm adaptor for ZEISS microscope (250-500µ)
QUANTEL MEDICAL
MIZ1
In Commercial Distribution

  • 03700542625255 ()


  • Laser adaptor

Keeler Vantage Plus IO - 03700542625248

Keeler Vantage Plus Indirect Ophthalmoscope
QUANTEL MEDICAL
LAFVP2
In Commercial Distribution

  • 03700542625248 ()


  • Indirect binocular laser ophthalmoscope

532nm adaptor for Keeler Vantage Plus IO (100µ) - 03700542625231

532nm adaptor for Keeler Vantage Plus Indirect Ophthalmoscope (100µ)
QUANTEL MEDICAL
810532IOVPST
In Commercial Distribution

  • 03700542625231 ()


  • Indirect binocular laser ophthalmoscope

532nm Heine Omega IO with integrated adaptor - 03700542625224

532nm Heine Omega Indirect Ophthalmoscope with integrated adaptor
QUANTEL MEDICAL
IOH810532
In Commercial Distribution

  • 03700542625224 ()


  • Indirect binocular laser ophthalmoscope

532nm adaptor for OPTIMIS FUSION - 03700542625217

Fold away 532nm adaptor for OPTIMIS FUSION (Single Spot)
QUANTEL MEDICAL
FUSION LINK (FUS1)
In Commercial Distribution

  • 03700542625217 ()


  • Laser adaptor

532nm adaptor for OPTIMIS II - 03700542625200

532nm adaptor for OPTIMIS II (Single Spot)
QUANTEL MEDICAL
532OPT2STD
In Commercial Distribution

  • 03700542625200 ()


  • Laser adaptor

532nm adaptor for CSO 980 Slit Lamp - 03700542625194

532nm adaptor for CSO 980 Slit Lamp (Single Spot)
QUANTEL MEDICAL
532CSO3ST
In Commercial Distribution

  • 03700542625194 ()


  • Laser adaptor

532nm adaptor for ZEISS 130 Slit Lamp - 03700542625187

532nm adaptor for ZEISS 130 Slit Lamp (Single Spot)
QUANTEL MEDICAL
532CZ130
In Commercial Distribution

  • 03700542625187 ()


  • Laser adaptor

532nm adaptor for ZEISS 120 Slit Lamp - 03700542625170

532nm adaptor for ZEISS 120 Slit Lamp (Single Spot)
QUANTEL MEDICAL
532CZ120
In Commercial Distribution

  • 03700542625170 ()


  • Laser adaptor

532nm adaptor for ZEISS 30 Slit Lamp - 03700542625163

532nm adaptor for ZEISS 30 Slit Lamp (Single Spot)
QUANTEL MEDICAL
532CZ30
In Commercial Distribution

  • 03700542625163 ()


  • Laser adaptor

532nm adaptor for HS900 BM/BQ Slit Lamp - 03700542625156

Fold away 532nm adaptor for HS900 BM/BQ Slit Lamp (Single Spot)
QUANTEL MEDICAL
532HSDST
In Commercial Distribution

  • 03700542625156 ()


  • Laser adaptor

532nm adaptor for HS900 BM/BQ Slit Lamp - 03700542625149

Fixed 532nm adaptor for HS900 BM/BQ Slit Lamp (Single Spot)
QUANTEL MEDICAL
532BMBQMST2
In Commercial Distribution

  • 03700542625149 ()


  • Laser adaptor

VITRA - 03700542625132

Ophthalmic Laser Photocoagulator 532nm MonoSpot Laser Retinal Photocoagulation
QUANTEL MEDICAL
VITRA
In Commercial Distribution

  • 03700542625132 ()


  • Ophthalmic solid-state laser system

Pachymetry Probe - 03700542625125

Corneal thickness measurement probe.
QUANTEL MEDICAL
P1
In Commercial Distribution

  • 03700542625125 ()


  • Ophthalmic ultrasound imaging transducer

A Standardized Probe - 03700542625118

Digitally programmed S-shaped amplifier characteristics and comprehensive design criteria for standardized echography and tissue differentiation according to Karl C. Ossoinig MD
QUANTEL MEDICAL
Std-A
In Commercial Distribution

  • 03700542625118 ()


  • Ophthalmic ultrasound imaging transducer

PROBEAM Biometry Probe - 03700542625101

Axial length measurement probe with an integrated laser pointer for biometry: - Ensuring the acquisition in the visual axis - Increasing the patient cooperation - Accelerating the speed of acquisition of A scans
QUANTEL MEDICAL
TP-02-las
In Commercial Distribution

  • 03700542625101 ()


  • Ophthalmic ultrasound imaging transducer

Biometry Probe - 03700542625095

Axial length measurement probe.
QUANTEL MEDICAL
TP-01 / TP-01-b
In Commercial Distribution

  • 03700542625095 ()


  • Ophthalmic ultrasound imaging transducer

LIN 50MHz Probe - 03700542625088

50 MHz probe reveals what you can not see with OCT alone, enabling the operator to visualize the structures located behind the iris such as ciliary bodies, the processes and lens zonules. Linear scanning offers the greatest signal intensity, providing superior anterior chamber image quality as the probe is always perpendicular with the tissue interface of interest.
QUANTEL MEDICAL
BHF-50LIN AVISO
In Commercial Distribution

  • 03700542625088 ()


  • Ophthalmic ultrasound imaging transducer

B Probe 10MHz COMPACT TOUCH - 03700542625071

10 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
In Commercial Distribution

  • 03700542625071 ()


  • Ophthalmic ultrasound imaging transducer

B Probe 20MHz AVISO - 03700542625064

No Description
QUANTEL MEDICAL
B-HF AVISO
In Commercial Distribution

  • 03700542625064 ()


  • Ophthalmic ultrasound imaging transducer

B Probe 10MHz AVISO - 03700542625057

10 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 AVISO
In Commercial Distribution

  • 03700542625057 ()


  • Ophthalmic ultrasound imaging transducer

POCKET - 03700542625040

Ultrasonic Pachymeter for Glaucoma Screening and Refractive Surgery.
QUANTEL MEDICAL
POCKET II
In Commercial Distribution

  • 03700542625040 ()


  • Ultrasound pachymeter

AXIS NANO - 03700542625033

Ophthalmic Ultrasound Biometer: Biometry and IOL Calculation The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement.
QUANTEL MEDICAL
AXIS NANO
In Commercial Distribution

  • 03700542625033 ()


  • Ophthalmic ultrasound imaging system

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
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