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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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Medline - 10193489001464

SCREW, CANN, HEADED, FT, 7.0 X 100MM
MEDLINE INDUSTRIES, INC.
MSDF7000
In Commercial Distribution

  • 10193489001464 ()
MSDF7000

  • Orthopaedic bone screw (non-sliding)

Medline - 10193489001167

INFANT, RESUS, BAG, FILT, PEEP, MANO
MEDLINE INDUSTRIES, INC.
CPRM3312FPM3
In Commercial Distribution

  • 20193489001164 ()
  • 10193489001167 ()
CPRM3312FPM3

  • Resuscitator face mask, single-use

Medline - 10193489001150

PED, RESUS, BAG, FILT, PEEP, MANO 3 MASK
MEDLINE INDUSTRIES, INC.
CPRM2216FPM3
In Commercial Distribution

  • 20193489001157 ()
  • 10193489001150 ()
CPRM2216FPM3

  • Resuscitator face mask, single-use

Medline - 10193489000962

PLATE, LAPIDUS, DUAL MODE, RIGHT
MEDLINE INDUSTRIES, INC.
MPP2200R
In Commercial Distribution

  • 10193489000962 ()
MPP2200R

  • Orthopaedic fixation plate, non-bioabsorbable

Medline - 10193489000955

PLATE, LAPIDUS, DUAL MODE, LEFT
MEDLINE INDUSTRIES, INC.
MPP2200L
In Commercial Distribution

  • 10193489000955 ()
MPP2200L

  • Orthopaedic fixation plate, non-bioabsorbable

MEDLINE - 10193489000658

MSC600LTXL @COMFORTGLIDE LT XL SHEET GRE
MEDLINE INDUSTRIES, INC.
MSC600LTXLR
In Commercial Distribution

  • 20193489000655 ()
  • 10193489000658 ()
MSC600LTXLR

  • Inflatable patient transfer sliding mattress, reprocessed

Aero-Med - 10192253068740

FNA Specimen Collection Kit, Northwell Health Only
AERO-MED, LLC
CA38075B
In Commercial Distribution

  • 50192253068748 ()
  • 10192253068740 ()
CA38075B

  • General specimen collection kit

Dover - 10192253067682

Silver Coated 100% Silicone Foley Catheter 30 mL, 3-Way 24 Fr/Ch (8.0 mm)
Cardinal Health 200, LLC
665241IC
In Commercial Distribution

  • 20192253067689 ()
  • 10192253067682 ()
  • 50192253067680 ()

  • Total Volume: 30 Milliliter
  • Catheter Gauge: 24 French
665241IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253067675

Silver Coated 100% Silicone Foley Catheter, 30 mL, 3-Way, 22 Fr/Ch (7.3 mm)
Cardinal Health 200, LLC
665225IC
In Commercial Distribution

  • 50192253067673 ()
  • 20192253067672 ()
  • 10192253067675 ()

  • Catheter Gauge: 22 French
  • Total Volume: 30 Milliliter
665225IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253067668

Silver Coated 100% Silicone Foley Catheter, 30 mL, 3-Way, 20 Fr/Ch (6.7 mm)
Cardinal Health 200, LLC
665209IC
In Commercial Distribution

  • 20192253067665 ()
  • 10192253067668 ()
  • 50192253067666 ()

  • Catheter Gauge: 20 French
  • Total Volume: 30 Milliliter
665209IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253067651

Silver Coated 100% Silicone Foley Catheter, 30 mL, 3-Way, 18 Fr/Ch (6.0 mm)
Cardinal Health 200, LLC
665183IC
In Commercial Distribution

  • 50192253067659 ()
  • 20192253067658 ()
  • 10192253067651 ()

  • Catheter Gauge: 18 French
  • Total Volume: 30 Milliliter
665183IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066401

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 30 CC, 2-WAY, 26 FR (8.7 MM)
Cardinal Health 200, LLC
630260IC
In Commercial Distribution

  • 50192253066409 ()
  • 20192253066408 ()
  • 10192253066401 ()
630260IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066395

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 30 CC, 2-WAY, 24 FR (8.0 MM)
Cardinal Health 200, LLC
630245IC
In Commercial Distribution

  • 50192253066393 ()
  • 20192253066392 ()
  • 10192253066395 ()
630245IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066388

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 30 CC, 2-WAY, 22 FR (7.3 MM)
Cardinal Health 200, LLC
630229IC
In Commercial Distribution

  • 50192253066386 ()
  • 20192253066385 ()
  • 10192253066388 ()
630229IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066371

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 30 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
630203IC
In Commercial Distribution

  • 50192253066379 ()
  • 20192253066378 ()
  • 10192253066371 ()
630203IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066364

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 30 CC, 2-WAY, 18 FR (6.0 MM)
Cardinal Health 200, LLC
630187IC
In Commercial Distribution

  • 20192253066361 ()
  • 10192253066364 ()
  • 50192253066362 ()
630187IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066357

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 26 FR (8.7 MM)
Cardinal Health 200, LLC
605262IC
In Commercial Distribution

  • 20192253066354 ()
  • 10192253066357 ()
  • 50192253066355 ()
605262IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066340

Silver Coated 100% Silicone Foley Catheter 5 mL, 2-Way 24 Fr/Ch (8.0 mm)
Cardinal Health 200, LLC
605247IC
In Commercial Distribution

  • 20192253066347 ()
  • 10192253066340 ()
  • 50192253066348 ()
605247IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066333

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 22 FR (7.3 MM)
Cardinal Health 200, LLC
605221IC
In Commercial Distribution

  • 20192253066330 ()
  • 10192253066333 ()
  • 50192253066331 ()
605221IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066326

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
605205IC
In Commercial Distribution

  • 50192253066324 ()
  • 20192253066323 ()
  • 10192253066326 ()
605205IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066319

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 18 FR (6.0 MM)
Cardinal Health 200, LLC
605189IC
In Commercial Distribution

  • 50192253066317 ()
  • 20192253066316 ()
  • 10192253066319 ()
605189IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066302

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 16 FR (5.3 MM)
Cardinal Health 200, LLC
605163IC
In Commercial Distribution

  • 50192253066300 ()
  • 20192253066309 ()
  • 10192253066302 ()
605163IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066296

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 14 FR (4.7 MM)
Cardinal Health 200, LLC
605148IC
In Commercial Distribution

  • 50192253066294 ()
  • 20192253066293 ()
  • 10192253066296 ()
605148IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066289

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 5 CC, 2-WAY, 12 FR (4.0 MM)
Cardinal Health 200, LLC
605122IC
In Commercial Distribution

  • 50192253066287 ()
  • 20192253066286 ()
  • 10192253066289 ()
605122IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066272

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 30 CC, 2-WAY
Cardinal Health 200, LLC
23020ICC
In Commercial Distribution

  • 20192253066279 ()
  • 10192253066272 ()
  • 50192253066270 ()
23020ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066265

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 18 FR (6.0 MM), 30 CC, 2-WAY
Cardinal Health 200, LLC
23018ICC
In Commercial Distribution

  • 50192253066263 ()
  • 20192253066262 ()
  • 10192253066265 ()
23018ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066258

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 22 FR (7.3 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20522ICC
In Commercial Distribution

  • 20192253066255 ()
  • 10192253066258 ()
  • 50192253066256 ()
20522ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066241

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20520ICC
In Commercial Distribution

  • 20192253066248 ()
  • 10192253066241 ()
  • 50192253066249 ()
20520ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066234

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 18 FR (6.0 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20518ICC
In Commercial Distribution

  • 50192253066232 ()
  • 20192253066231 ()
  • 10192253066234 ()
20518ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066227

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 16 FR (5.3 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20516ICC
In Commercial Distribution

  • 50192253066225 ()
  • 20192253066224 ()
  • 10192253066227 ()
20516ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066210

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 14 FR (4.7 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20514ICC
In Commercial Distribution

  • 20192253066217 ()
  • 10192253066210 ()
  • 50192253066218 ()
20514ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066203

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 12 FR (4.0 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20512ICC
In Commercial Distribution

  • 20192253066200 ()
  • 10192253066203 ()
  • 50192253066201 ()
20512ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253065626

100 percent Silicone Urine Meter Foley Tray with coude tip
Cardinal Health 200, LLC
P4P18CSDK2
In Commercial Distribution

  • 50192253065624 ()
  • 10192253065626 ()
P4P18CSDK2

  • Indwelling urethral catheterization kit, adult

Dover - 10192253065619

100 percent silicone Urine Meter Foley Tray with coude tip
Cardinal Health 200, LLC
P4P16CSDK2
In Commercial Distribution

  • 50192253065617 ()
  • 10192253065619 ()
P4P16CSDK2

  • Indwelling urethral catheterization kit, adult

Dover - 10192253065497

100 percent Silicone Silver Hydrogel Coated Urine Meter Foley Tray with Coude Tip
Cardinal Health 200, LLC
P4P18XCSDK2
In Commercial Distribution

  • 50192253065495 ()
  • 10192253065497 ()
P4P18XCSDK2

  • Indwelling urethral catheterization kit, adult

Dover - 10192253065480

100 percent Silicone Silver Hydrogel Coated Urine Meter Foley Tray with Coude tip
Cardinal Health 200, LLC
P4P16XCSDK2
In Commercial Distribution

  • 50192253065488 ()
  • 10192253065480 ()
P4P16XCSDK2

  • Indwelling urethral catheterization kit, adult

Kendall - 10192253065473

Finished product, non-sterile, Kendall DL, 6 Lead, GE CARESCAPE ONE only Product code 33532
Cardinal Health 200, LLC
33532
In Commercial Distribution

  • 50192253065471 ()
  • 10192253065473 ()
33532

  • Electrocardiographic lead switching adaptor

Kendall - 10192253065466

Finished product, non-sterile, Kendall DL, 3 or 5 Lead, GE CARESCAPE ONE only Product code 33523
Cardinal Health 200, LLC
33523
In Commercial Distribution

  • 50192253065464 ()
  • 10192253065466 ()
33523

  • Electrocardiographic lead switching adaptor

Aero-Med - 10192253065435

Kit HSV for University of Kansas Only
AERO-MED, LLC
CA49750
In Commercial Distribution

  • 50192253065433 ()
  • 10192253065435 ()
CA49750

  • General specimen collection kit

Argyle - 10192253065237

Trocar Catheter
Cardinal Health 200, LLC
888561068K
In Commercial Distribution

  • 50192253057278 ()
  • 10192253065237 ()

  • Length: 15.75 Inch
  • Catheter Gauge: 28 French
888561068K

  • Closed-wound drain, non-bioabsorbable

Monoject - 10192253064322

Monoject™ 1mL Insulin Needle and Syringe 31G x 15/64" (0.25 x 6mm)
Cardinal Health 200, LLC
8881613110
In Commercial Distribution

  • 20192253064329 ()
  • 10192253064322 ()
  • 50192253064320 ()

  • Needle Gauge: 31 Gauge
  • Length: 6 Millimeter
  • Total Volume: 1 Milliliter
8881613110

  • Insulin syringe/needle, basic

Monoject - 10192253064315

Monoject™ 0.5 mL Insulin Syringe Permanent Needle 31G x 15/64'' (0.25 x 6 mm)
Cardinal Health 200, LLC
8881613150
In Commercial Distribution

  • 20192253064312 ()
  • 10192253064315 ()
  • 50192253064313 ()

  • Length: 6 Millimeter
  • Needle Gauge: 31 Gauge
  • Total Volume: 0.5 Milliliter
8881613150

  • Insulin syringe/needle, basic

Monoject - 10192253064308

Monoject™ 0.3 mL Insulin Syringe Permanent Needle 31G x 15/64'' (0.25 x 6 mm)
Cardinal Health 200, LLC
8881613130
In Commercial Distribution

  • 20192253064305 ()
  • 10192253064308 ()
  • 50192253064306 ()

  • Needle Gauge: 31 Gauge
  • Total Volume: 0.3 Milliliter
  • Length: 6 Millimeter
8881613130

  • Insulin syringe/needle, basic

Monoject - 10192253063271

Tuberculin Safety Syringe with Needle
Cardinal Health 200, LLC
8881511201
Not in Commercial Distribution

  • 20192253063278 ()
  • 10192253063271 ()
  • 50192253063279 ()

  • Needle Gauge: 28 Gauge
  • Length: 0.5 Inch
8881511201

  • Insulin syringe/needle, safety

ENDOVAGINAL PROBE - 04987670001505

ENDOVAGINAL PROBE
CANON MEDICAL SYSTEMS CORPORATION
PVG-601V
In Commercial Distribution

  • 04987670001505 ()


  • Rectal/vaginal ultrasound imaging transducer

SYSTEM TABLE - 04987669100806

The ST-5100 is the system table on which the NIDEK REFRACTOR RT-5100 is installed. The table allows the SSC-330/350, AR/ARK series, and LM-500/LM-600 series/LM-1800 series to be combined into an ophthalmic workstation. The table is composed of a refractor arm, motorized main table, and side table. The main table, which is electrically extendable up to 180 mm, has an RT arm, rotatable with one touch, simple operation, and a tray to hold an auto refractometer (AR/ARK series). The side table is for installing the SSC-330/350 or LM-500/LM-600 series/LM-1800 series. It is equipped with drawers for trial lenses and space for a computer and printer.
NIDEK CO.,LTD.
ST-5100
In Commercial Distribution

  • 04987669100806 ()


  • Instrument table

OPTICAL BIOMETER - 04987669100547

The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.
NIDEK CO.,LTD.
AL-Scan
In Commercial Distribution

  • 04987669100547 ()


  • Optical pachymeter
  • Ophthalmic examination slit lamp
  • Bench-top keratometer
  • Ophthalmic ultrasound imaging system

SPECULAR MICROSCOPE - 04987669100530

The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up, and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses. Observation is possible in the central area (visual angle: 5°) and peripheral area (visual angle: 27°) using a periphery capture function as well as in the center of the cornea. The captured images and analysis results can be printed on the built-in printer or optional video printer, or output to an external device over LAN connection.
NIDEK CO.,LTD.
CEM-530
In Commercial Distribution

  • 04987669100530 ()


  • Optical pachymeter
  • Direct ophthalmoscope, line-powered

ECHOSCAN - 04987669100455

The NIDEK US-500 Echoscan is an ultrasonic device to measure the axial length and corneal thickness and provide the information to be used for diagnosis. Axial length is one of the parameters used to determine the refractive power of an IOL prior to cataract surgery. By inputting the measured axial length with other parameters, the refractive power of an IOL can be calculated. Corneal thickness is a necessary parameter when considering the clinical influence of surgery, drugs and contact lenses upon endothelium tissue. Pachymetry is now commonly performed prior to and after corneal refractive surgery using devices such as the excimer laser. The US-500 is comprised of a touch screen, main body with a built-in printer, Pachymetry probe, and foot switch.
NIDEK CO.,LTD.
US-500
In Commercial Distribution

  • 04987669100455 ()


  • Ophthalmic ultrasound imaging system
  • Ultrasound pachymeter

AUTO REF/KERATO/TONOMETER - 04987669100066

AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye.
NIDEK CO.,LTD.
TONOREF II
In Commercial Distribution

  • 04987669100066 ()


  • Ophthalmic tonometer, line-powered
  • Bench-top keratometer
  • Automated ophthalmic refractometer
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