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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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Nova - D79010601031

Nova Nitrile Powder-Free, Medium, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060103
In Commercial Distribution

  • D79010601033 ()
  • D79010601031 ()
  • D79010601030 ()
1060103

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601021

Nova Nitrile Powder-Free, Small, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060102
In Commercial Distribution

  • D79010601023 ()
  • D79010601021 ()
  • D79010601020 ()
1060102

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nova - D79010601011

Nova Nitrile Powder-Free, X-Small, Super-stretchy nitrile, Textured fingertips, Very durable, Violet-blue in color, Packaging contains at least 70% recycled material
PURELIFE, LLC
1060101
In Commercial Distribution

  • D79010601013 ()
  • D79010601011 ()
  • D79010601010 ()
1060101

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Titan - 00817914020426

Scoville-Greenwood Bayonet Bipolar Forcep 7 3/4" (196.85mm) Insulated With A With A 0.25mm Tip (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
162018239010101
In Commercial Distribution

  • 00817914020426 ()

  • Length: 196.85 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

MR PHACO - G412CA3200

Healon/Viscoelastic Injection Cannula 21ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA320
In Commercial Distribution

  • G412CA3200 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412CA2920

Anis Cortex Aspirating Cannula 23gatw Angled 35 Degree at 1.5mm from bend to tip, .4mm Port, 26mm Overall Length, Sandblasted
Crestpoint Management Limited
CA292
In Commercial Distribution

  • G412CA2920 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412CA16310

Buratto Hydrodissectional Cannula 25ga Flattened .6mm tip, Angled/Vaulted 14mm from bend to tip at 50 Degrees, 18mm Overall Length
Crestpoint Management Limited
CA1631
In Commercial Distribution

  • G412CA16310 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412CA14260

Healon/Viscoelastic Injection Cannula 27ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1426
In Commercial Distribution

  • G412CA14260 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412CA14250

Healon/Viscoelastic Injection Cannula 19ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1425
In Commercial Distribution

  • G412CA14250 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412CA14240

Healon/Viscoelastic Injection Cannula 18ga, Flattened Round Tip, Angled 5mm from bend to tip at 40 degree, 29mm Overall Length
Crestpoint Management Limited
CA1424
In Commercial Distribution

  • G412CA14240 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412PH2443T0

TTI-McPherson Tying Forceps Angled 10.5mm at 45 Degree, with 10mm Smooth Tying Platform, Round Knurled Handle, 105mm Overall Length, Titanium
Crestpoint Management Limited
PH2443T
In Commercial Distribution

  • G412PH2443T0 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH2032T0

Bechert-McPherson Tying Forceps Angled 10.5mm at 45 Degree, with 10mm Smooth Tying Platform, Serrated Flat Handle, 84mm Overall Length, Titanium
Crestpoint Management Limited
PH2032T
In Commercial Distribution

  • G412PH2032T0 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412CA4360

Seeley Hydrodissection Cannula 26ga, Angled 12mm from bend to tip at 45 Degree, Flattened 2mm Horizontal Tip, 12mm Overall Length
Crestpoint Management Limited
CA436
In Commercial Distribution

  • G412CA4360 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable

MR PHACO - G412PH1028T0

Colibri Utility Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, Oval Hole Flat Handle, 75mm Overall Length, Titanium
Crestpoint Management Limited
PH1028T
In Commercial Distribution

  • G412PH1028T0 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH66060

Fogla Fine-Pointed Dissector, Angled 60 Degree at 5mm from bend to tip, Round Knurled Handle, 114mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH6606
In Commercial Distribution

  • G412PH66060 ()


  • Soft-tissue surgical hook, reusable

Integra® Miltex® - 10381780488088

Integra® Miltex® Sims Rectal Speculum, 6", Fenestrated Blades, 3-1/2" Deep x 5/8" Wide At Distal End
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MH28-2
In Commercial Distribution

  • H834MH2820 ()
  • 10381780488088 ()
MH28-2

  • Rectal speculum

Ambler Surgical - 00190660076122

Troutman-Barraquer colibri corneal forceps, 2 7/8'', 0.3mm 1x2 teeth set at 45 degrees, 6.0mm tying platforms, flat handle, titanium
AMBLER SURGICAL CORP.
Troutman-Barraquer colibri corneal forceps
In Commercial Distribution

  • 00190660076122 ()
2223T

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660063528

Maumenee cross-action colibri corneal forceps, 4 3/4'', 0.1mm 1x2 teeth set at 90 degrees, 5.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Maumenee cross-action colibri corneal forceps
In Commercial Distribution

  • 00190660063528 ()
2232E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

Ambler Surgical - 00190660063511

Maumenee cross-action colibri corneal forceps, 4 3/4'', 0.1mm 1x2 teeth set at 45 degrees, 5.0mm tying platforms, flat handle
AMBLER SURGICAL CORP.
Maumenee cross-action colibri corneal forceps
In Commercial Distribution

  • 00190660063511 ()
2231E

  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

PRO-FUSE® - 00884908148923

9.6F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT SILICONE CATHETER W/5FSILICONE C Micro-Stick®INTRODUCER SE
Medical Components, Inc.
MIPP96AFS
Not in Commercial Distribution

  • 50884908148928 ()
  • 00884908148923 ()
MIPP96AFS

  • Vascular port/catheter

MSI Precision Specialty Instruments - 00194613105860

Day Ear Hook, Medium, 2mm Blunt Tip, Angled At 90 Degrees, Small Round Knurled Handle, Overall Length 6-1/3" (159mm)
Med Saver, Inc.
114-1581-2
In Commercial Distribution

  • 00194613105860 ()


  • Soft-tissue surgical hook, reusable

MSI Precision Specialty Instruments - 00194613085322

House Crabtree Dissector Pick, 1.5mm Flattened Tip Angled At 90 Degrees, Straight Shaft, Round Handle, Overall Length 6-1/2" (167mm)
Med Saver, Inc.
114-2816-83J
In Commercial Distribution

  • 00194613085322 ()


  • Open-surgery dissector

MSI Precision Specialty Instruments - 00194613085179

Nagahara Ambidextrous Nucleus Chopper, 1.5mm Tip, Blade Set At 90 Degrees Angle, Round Knurled Handle, Overall Length 4-1/2" (110mm)
Med Saver, Inc.
15-3626AS
In Commercial Distribution

  • 00194613085179 ()


  • Ophthalmic knife, reusable

MSI Precision Specialty Instruments - 00194613108892

O'Gawa Tying Forceps, Curved, 5.5mm Tying Platform, 0.3mm Gap At Platform Heel, Round Knurled Handle, Overall Length 4-1/8" (105mm)
Med Saver, Inc.
5-2992
In Commercial Distribution

  • 00194613108892 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable

MSI Precision Specialty Instruments - 00194613022136

House Crabtree Dissector Pick, 1.5mm Flattened Tip Angled At 90 Degrees, Straight Shaft, Round Handle, Overall Length 6-1/2" (167mm)
Med Saver, Inc.
114-2816-83JS
In Commercial Distribution

  • 00194613022136 ()


  • Open-surgery dissector

AlcoMate - 00853464001416

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM3500FC
In Commercial Distribution

  • 00853464001416 ()
AKG-SM3500FC

  • Alcohol breath analyser

AlcoMate - 00853464001409

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM3100
In Commercial Distribution

  • 00853464001409 ()
AKG-SM3100

  • Alcohol breath analyser

AlcoMate - 00853464001393

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM600
In Commercial Distribution

  • 00853464001393 ()
AKG-SM600

  • Alcohol breath analyser

AlcoMate - 00853464001348

Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
AK Globaltech Corp
SM200
In Commercial Distribution

  • 00853464001348 ()
AKG-SM200

  • Alcohol breath analyser

BPro® Ambulatory Blood Pressure Monitoring System - 08885014410012

BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.
HEALTHSTATS INTERNATIONAL PTE LTD
T6200 Series
Not in Commercial Distribution

  • 08885014410012 ()


  • Blood pressure ambulatory recorder

STERLINK™ - 08800066500184

Terragene Bionova® SCBI(BT96) is a self-contained biological indicator inoculated with viable 10^6 Geobacillus sterotheromophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydorgen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60 degree celsius.
Plasmapp Co.,Ltd.
BT96
In Commercial Distribution

  • 08800066500184 ()


  • Biological sterilization indicator

Provent Sleep Therapy - 00868020000208

Provent 30 Night Standard Pack contains 30 Standard resistance Provent
PROVENT SLEEP THERAPY, LLC
CAT1105
In Commercial Distribution

  • 00868020000208 ()

  • Expiratory Resistance 3.0 >= x < 8.0 cm H2O at 50 mL/sec flow rate per nostril
CAT1105

  • Nasal dilator

ComPel Isolation Gown - 00634916792713

ComPel Isolation Gown, 3 Armhole, AAMI Level 2, XL, Wrap Around, Velcro at Shoulder, Bound All Around, Long Sleeves with Cuffs
STANDARD TEXTILE CO., INC.
661Y4804
In Commercial Distribution

  • 00634916792713 ()


  • Isolation gown, reusable

Power Dental USA - D94381007

PIEZO BONE SURGERY TIPS FOR SURGIMASTER AND SURGIMASTER II,DUS5 SHARP AT THREE SIDES HARVESTER TO HARVEST AUTOGENOUS BONE BLOCKS, RIDGE.
Power Dental U.S.A. Inc.
8100-7
In Commercial Distribution

  • D94381007 ()
8100-7

  • Dressing/utility forceps, scissors-like, reusable
  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal

AlcoMate - 00853464001119

The 2nd Generation Re-Inforced Semiconductor Sensor by AlcoMate. Replacement needed every 200 tests or at least once yearly, whichever comes first.
AK Globaltech Corp
SM7000
In Commercial Distribution

  • 00853464001119 ()
AKG SM7000

  • Alcohol breath analyser

Transport shelf - 00670482000722

The transport shelf is an accessory. It's intended to be installed at foot end of the bed in the corner bumper.
Umano Medical Inc
299-0523WG-TRI
In Commercial Distribution

  • 00670482000722 ()
  • 10670482000729 ()


  • Basic electric hospital bed

CORTAC® - 00650551050100

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093
In Commercial Distribution

  • 00650551050100 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-08-093

  • Cortical electrode

CORTAC® - 00650551087328

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062-NS
In Commercial Distribution

  • 00650551087328 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-062-NS

  • Cortical electrode

CORTAC® - 00650551062844

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066
In Commercial Distribution

  • 00650551062844 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066

  • Cortical electrode

CORTAC® - 00650551062837

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066
In Commercial Distribution

  • 00650551062837 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111-16-066

  • Cortical electrode

CORTAC® - 00650551062769

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062
In Commercial Distribution

  • 00650551062769 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-062

  • Cortical electrode

CORTAC® - 00650551062752

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-062
In Commercial Distribution

  • 00650551062752 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-062

  • Cortical electrode

CORTAC® - 00650551074670

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, RADIOPAQUE "L" AT CONTACT #1 & #8, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-093-NS
In Commercial Distribution

  • 00650551074670 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-093-NS

  • Cortical electrode

CORTAC® - 00650551087410

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-066-NS
In Commercial Distribution

  • 00650551087410 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2111TX-16-066-NS

  • Cortical electrode

CORTAC® - 00650551087403

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 2X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111-16-066-NS
In Commercial Distribution

  • 00650551087403 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111-16-066-NS

  • Cortical electrode

CORTAC® - 00650551087335

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2111TX-16-062-NS
In Commercial Distribution

  • 00650551087335 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2111TX-16-062-NS

  • Cortical electrode

ever GUIDE KIT - 08806343924049

It is used when removing the gums at the location where the fixture will be installed during dental implant fixture surgery.
Shinhung MST Co., Ltd.
GTP35
In Commercial Distribution

  • 08806343924049 ()


  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Multimeter MagicMaX-Universal - EIBAVD02020100

Multimeter MagicMaX developed in accordance with IEC 61674. Flexible solution for exact dose- and kV-measurements at all X-ray units incl. CT.
IBA Dosimetry GmbH
VD0202010
In Commercial Distribution

  • EIBAVD02020100 ()
VD0202010

  • Diagnostic x-ray system quality assurance device

Novo Surgical Inc. - 00842331143618

nagahara nucleus chopper, 1.25 mm tip & blade offset at 60 degree angle, round knurled handle, 4 1/2" (11.4 cm), left
NOVO SURGICAL, INC.
OP7122-25
In Commercial Distribution

  • 00842331143618 ()
OP7122-25

  • Eye muscle hook, reusable

Novo Surgical - 00842331195273

frazier suction tube, tube length 4" (100.0 mm), calibrations marked at 5.0 - 9.0 cm, 6 3/4" (17.0 cm), 7 fr.
NOVO SURGICAL, INC.
E7486-68
In Commercial Distribution

  • 00842331195273 ()

  • Length: 17 Centimeter
E7486-68

  • Airway suction catheter
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