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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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Professional Hand Evaluation Kit - 00855170007119

The Lafayette Grip or Pinch Dynamometers are hydraulic strength measuring instruments. They are designed for routine assessment of the grip and/or pinch strength of a patient or can also be used in the evaluation of hand trauma or disease. As the patient either grips or pinches the device, a column of hydraulic fluid activates a pressure gauge mounted on the top of the device. The gauge indicates the pinch or grip force in pounds (lbs) or kilogram force (kgf). A peak needle shows the maximum force applied during a single test. The peak needle is manually reset at the end of the test and peak values are recorded manually. The grip dynamometers also feature an adjustable handle that can accommodate five different grip positions. The Stainless Steel Short Finger Goniometer is used for easy range-of-motion measurements of metacarpal, phalangeal, and interphalangeal joints. There are linear inch and centimeter markings on both sides of the protractors, in opposite directions. The protractors measure 0-150° in 5° increments. Stainless steel. Latex free. Clearly marked numbers make measuring easy. Measures 5.75 inches long.
LAFAYETTE INSTRUMENT COMPANY, INC.
5030K1
In Commercial Distribution

  • 00855170007119 ()
5030K1

  • Hand dynamometer/pinchmeter, mechanical
  • Manual goniometer

ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG - 07898671250496

KIT WITH UNIVERSAL FLOW SENSOR, FLOW SENSOR LINE, EXHALATION VALVE, AND DIAPHRAGM FOR USE WITH OXYMAG, SINGLE-USE
MAGNAMED TECNOLOGIA MEDICA SA
1709953
In Commercial Distribution

  • 07898671250496 ()
1709953

  • Breathing circuit gas-flow sensor, single-use
  • Mechanical expiratory valve, single-use

3M™ Nexcare™ - 30051141994971

Nexcare™ Foot Protection Tape, FPT-05, 0 x 0 (0 x 0)
3M COMPANY
FPT-05
In Commercial Distribution

  • 50051141994975 ()
  • 30051141994971 ()
  • 00051141994970 ()
FPT-05

  • Hypoallergenic skin adhesive tape

Welch Allyn, Inc. - 00732094285444

Surveyor Central Repeater Node - English language and CD manual; 220V power; 0; Color LCD 24 in. monitor with high resolution
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094285444 ()
SCREP-AAB-XXBXX

  • Centralized patient monitor

ATRAMAT - 07500142003974

ATRAMAT NYLON SURGICAL SUTURE BLACK USP 0 EP 3,5, 45 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
NYLON
In Commercial Distribution

  • 07500142103971 ()
  • 07500142003974 ()
  • 07500142203978 ()

  • Length: 24 Millimeter
  • USP 0 EP 3,5
CE2441-N

  • Nylon suture, non-bioabsorbable, monofilament

ATRAMAT - 07500142001987

ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 0 EP 3,5, 45 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
POLYPROPILENE
In Commercial Distribution

  • 07500142101984 ()
  • 07500142001987 ()

  • Length: 24 Millimeter
  • USP 0 EP 3,5
CE2461

  • Polyolefin/fluoropolymer suture, monofilament

Y-Connector - 04251783104195

Y-Connector
Assamed GmbH - Medizinbedarf
06016400
In Commercial Distribution

  • 14251783104192 ()
  • 04251783104195 ()
  • 24251783104199 ()


  • Suction/irrigation tubing, reusable

Reusable Irrigation Tubing Set for elcoMED SA 200/ SA200C 2.2 m - 04251783104171

Reusable Irrigation Tubing Set for elcoMED SA 200/ SA200C 2.2 m
Assamed GmbH - Medizinbedarf
04976700
In Commercial Distribution

  • 14251783104178 ()
  • 04251783104171 ()
  • 24251783104175 ()

  • Length: 2.2 Meter


  • Suction/irrigation tubing, reusable

Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C - 04251783104133

Y-switch with irrigation tube for motor 2, elco MED SA 200 / SA 200C
Assamed GmbH - Medizinbedarf
04366300
In Commercial Distribution

  • 14251783104130 ()
  • 04251783104133 ()
  • 24251783104137 ()


  • Surgical irrigation tubing set, single-use

Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m - 04251783104119

Irrigation Tubing Set for ElcoMED SA 200/ SA 200C 3.8 m
Assamed GmbH - Medizinbedarf
04365100
In Commercial Distribution

  • 14251783104116 ()
  • 04251783104119 ()
  • 24251783104113 ()

  • Length: 3.8 Meter


  • Surgical irrigation tubing set, single-use

577nm adaptor for ZEISS 130 Slit Lamp - 03700542625385

No Description
QUANTEL MEDICAL
577CZ130ST
In Commercial Distribution

  • 03700542625385 ()


  • 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

SUPRA - 03700542625286

532nm Ophthalmic Laser System used for Retinal Photocoagulation
QUANTEL MEDICAL
SUPRA
In Commercial Distribution

  • 03700542625286 ()


  • Ophthalmic solid-state laser system

532-577nm adaptor for LEICA microscope - 03700542625262

532-577nm adaptor for LEICA microscope (250-500µ)
QUANTEL MEDICAL
MIL1
In Commercial Distribution

  • 03700542625262 ()


  • Laser adaptor

Keeler Vantage Plus IO - 03700542625248

Keeler Vantage Plus Indirect Ophthalmoscope
QUANTEL MEDICAL
LAFVP2
In Commercial Distribution

  • 03700542625248 ()


  • 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 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 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

PEDIGUARD THREADED - 03662674000464

No Description
SPINEGUARD
DSG Threaded Shaft A LK - Ø4.5mm
In Commercial Distribution

  • 03662674000464 ()
D1TA1007

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000457

No Description
SPINEGUARD
DSG Threaded Shaft A LK - Ø5.5mm
In Commercial Distribution

  • 03662674000457 ()
D1TA1001

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000365

No Description
SPINEGUARD
DSG Threaded Shaft F - Ø4.0mm
In Commercial Distribution

  • 03662674000365 ()
D1TA0006

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000358

No Description
SPINEGUARD
DSG Threaded Shaft K - Ø5.5mm
In Commercial Distribution

  • 03662674000358 ()
D1TA0014

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000341

No Description
SPINEGUARD
DSG Threaded Shaft K - Ø4.5mm
In Commercial Distribution

  • 03662674000341 ()
D1TA0013

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000327

No Description
SPINEGUARD
DSG Threaded Shaft B - Ø4.5mm
In Commercial Distribution

  • 03662674000327 ()
D1TA0011

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000310

No Description
SPINEGUARD
DSG Sleeve #2
In Commercial Distribution

  • 03662674000310 ()
D1ST0002

  • Orthopaedic implantation sleeve, reusable

PEDIGUARD THREADED - 03662674000303

No Description
SPINEGUARD
DSG Threaded Shaft J - Ø4.5mm
In Commercial Distribution

  • 03662674000303 ()
D1TA0010

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000297

No Description
SPINEGUARD
DSG Threaded Shaft H - Ø5.5mm
In Commercial Distribution

  • 03662674000297 ()
D1TA0009

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000280

No Description
SPINEGUARD
DSG Threaded Shaft G - Ø5.0mm
In Commercial Distribution

  • 03662674000280 ()
D1TA0008

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000273

No Description
SPINEGUARD
DSG Threaded Shaft A - Ø4.5mm
In Commercial Distribution

  • 03662674000273 ()
D1TA0007

  • Manual surgical rotary handpiece, reusable

PEDIGUARD THREADED - 03662674000266

No Description
SPINEGUARD
DSG Technology Instrument Set - Lid
In Commercial Distribution

  • 03662674000266 ()
D1TT2001

  • Instrument tray, reusable

PEDIGUARD THREADED - 03662674000259

No Description
SPINEGUARD
DSG Technology Instrument Set - Base
In Commercial Distribution

  • 03662674000259 ()
D1TT1001

  • Instrument tray, reusable
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