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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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DIASOL - B467CC51

Dialysate Additive 5.1 grams Calcium Chloride to increase Calcium by 0.5 mEq/L when added to 3.785 liters of concentrate proportioned at 1:35.83
DIASOL, INC.
CC5.1
In Commercial Distribution

  • B467CC51220 ()
  • B467CC51 ()

  • Weight: 5.1 Gram
CC2

  • Haemodialysis concentrate

DIASOL - B467CC157

Dialysate Additive 15.7 grams Calcium Chloride to increase Calcium by 0.5 mEq/L when added to 9.46 liters of concentrate proportioned at 1:44
DIASOL, INC.
CC15.7
In Commercial Distribution

  • B467CC157145 ()
  • B467CC157 ()

  • Weight: 15.7 Gram
CC10

  • Haemodialysis concentrate

MR PHACO - G412PH2439T0

Shepard Tying Forceps Angled with 4mm Tying Platform, Angled 4.5mm from bend to tip at 45 Degree, Serrated Flat Handle, 108mm Overall Length, Titanium
Crestpoint Management Limited
PH2439T
In Commercial Distribution

  • G412PH2439T0 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH23920

Harms-Colibri Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, with 6mm Tying Platform, Oval Hole Flat Handle, 75mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2392
In Commercial Distribution

  • G412PH23920 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH23880

Gills-Colibri Utility Forceps Very Fine Pointed Tips set at 45 Degree, with 6mm Tying Platform, Oval Hole Flat Handle, 75mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2388
In Commercial Distribution

  • G412PH23880 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH23820

Harms-Colibri Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, with 6mm Tying Platform, Three Hole Flat Handle, 106mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2382
In Commercial Distribution

  • G412PH23820 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412PH22460

Colibri Corneal Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, with 6mm Tying Platform, Serrated Flat Handle, 106mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2246
In Commercial Distribution

  • G412PH22460 ()


  • Ophthalmic surgical device handling forceps, reusable

MR PHACO - G412CA9840

Graether Collar Button 23ga, 0.25mm single port facing right, Roughened posterior surface, Angled 10mm from bend to tip at 45 degree, 22mm Overall Length
Crestpoint Management Limited
CA984
In Commercial Distribution

  • G412CA9840 ()


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

MR PHACO - G412CA9830

Graether Collar Button 23ga, 0.25mm single port facing left, Roughened posterior surface, Angled 10mm from bend to tip at 45 degree, 22mm Overall Length
Crestpoint Management Limited
CA983
In Commercial Distribution

  • G412CA9830 ()


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

MR PHACO - G412CA6500

Gills Welsh I/A Cannula 23ga Irrigating 25ga Aspirating, Angled 8mm at 30 Degree, Irrigation tip is .5mm behind Aspiration tip, 23mm Overall Length
Crestpoint Management Limited
CA650
In Commercial Distribution

  • G412CA6500 ()


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

MR PHACO - G412CA3550

Binkhorst Irrigating Cannula 22ga Left with 2.4mm (1mm ID) J-Shaped hook tip, Angled 30 Degree at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA355
In Commercial Distribution

  • G412CA3550 ()


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

MR PHACO - G412CA3500

Binkhorst Irrigating Cannula 22ga Right with 2.4mm (1mm ID) J-Shaped hook tip, Angled 30 Degrees at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA350
In Commercial Distribution

  • G412CA3500 ()


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

MR PHACO - G412CA14520

Binkhorst Irrigating Cannula 26ga Left with 2.1mm (1mm ID) J-Shaped hook tip, Angled 30 Degree at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA1452
In Commercial Distribution

  • G412CA14520 ()


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

MR PHACO - G412CA14510

Binkhorst Irrigating Cannula 25ga Left with 2.2mm (1mm ID) J-Shaped hook tip, Angled 30 Degree at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA1451
In Commercial Distribution

  • G412CA14510 ()


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

MR PHACO - G412CA14500

Binkhorst Irrigating Cannula 30ga Left with 1.8mm (1mm ID) J-Shaped hook tip, Angled 30 Degree at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA1450
In Commercial Distribution

  • G412CA14500 ()


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

MR PHACO - G412CA14490

Binkhorst Irrigating Cannula 27ga Left with 2.0mm (1mm ID) J-Shaped hook tip, Angled 30 Degree at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA1449
In Commercial Distribution

  • G412CA14490 ()


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

MR PHACO - G412CA14480

Binkhorst Irrigating Cannula 25ga Right with 2.2mm (1mm ID) J-Shaped hook tip, Angled 30 Degrees at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA1448
In Commercial Distribution

  • G412CA14480 ()


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

MR PHACO - G412CA14470

Binkhorst Irrigating Cannula 30ga Right with 1.8mm (1mm ID) J-Shaped hook tip, Angled 30 Degrees at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA1447
In Commercial Distribution

  • G412CA14470 ()


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

MR PHACO - G412CA14460

Binkhorst Irrigating Cannula 27ga Right with 2.0mm (1mm ID) J-Shaped hook tip, Angled 30 Degrees at 13mm from bend to tip, 35mm Overall Length
Crestpoint Management Limited
CA1446
In Commercial Distribution

  • G412CA14460 ()


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

Ambler Surgical - 00190660058890

Kelman-McPherson suturing forceps, 4 1/8'', angled 45 degrees shafts, 0.12mm 1x2 teeth set at 90 degrees, 8.0mm tying platforms, ergonomic fenestrated round handle
AMBLER SURGICAL CORP.
Kelman-McPherson suturing forceps
In Commercial Distribution

  • 00190660058890 ()
2358E

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

Azur - D79010617051

Azur Nitrile Powder-Free, X-Large, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061705
In Commercial Distribution

  • D79010617053 ()
  • D79010617051 ()
  • D79010617050 ()
1061705

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

Azur - D79010617041

Azur Nitrile Powder-Free, Large, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061704
In Commercial Distribution

  • D79010617043 ()
  • D79010617041 ()
  • D79010617040 ()
1061704

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

Azur - D79010617031

Azur Nitrile Powder-Free, Medium, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061703
In Commercial Distribution

  • D79010617033 ()
  • D79010617031 ()
  • D79010617030 ()
1061703

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

Azur - D79010617021

Azur Nitrile Powder-Free, Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061702
In Commercial Distribution

  • D79010617023 ()
  • D79010617021 ()
  • D79010617020 ()
1061702

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

Azur - D79010617011

Azur Nitrile Powder-Free, X-Small, Ultra-soft nitrile, Super stretchy for superior comfort, Packaging contains at least 80% recycled material, More gloves per box reduces packaging
PURELIFE, LLC
1061701
In Commercial Distribution

  • D79010617013 ()
  • D79010617011 ()
  • D79010617010 ()
1061701

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

Hayden Medical - 00840319715604

Harms-Colibri Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, with 6mm tying platform, oval hole flat handle, 75mm overall length, stainless steel
Hayden Medical, Inc.
E5-6170
In Commercial Distribution

  • 00840319715604 ()
E5-6170

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

PCRopsis - B5507837810000

PCRopsis™ Reagent RVD-RT (1000 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B5507837810000 ()
783781000

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B550783781000

PCRopsis™ Reagent RVD-RT (100 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783781000 ()
78378100

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B550783780250

PCRopsis™ Reagent RVD-RT (25 mL) mediates extraction-free PCR from saliva, urine, and swab specimens transported in compatible universal transport medium at room temperature.
ENTOPSIS, LLC
Reagent RVD-RT
Not in Commercial Distribution

  • B550783780250 ()
78378025

  • Nucleic acid extraction/isolation kit IVD

CORTAC® - 00650551056300

SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110TX-64-061
In Commercial Distribution

  • 00650551056300 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110TX-64-061

  • Cortical electrode

CORTAC® - 00650551056294

SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-64-061
In Commercial Distribution

  • 00650551056294 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110-64-061

  • Cortical electrode

CORTAC® - 00650551075882

SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT TAIL WITH #5 DEAD, 4X4, RADIOPAQUE MARKER AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-15-010-NS
In Commercial Distribution

  • 00650551075882 ()

  • Thickness 1.01 Millimeter
  • Contact Diameter 2 & 3 Millimeter
2110-15-010-NS

  • Cortical electrode

CORTAC® - 00650551080862

SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-64-061-NS
In Commercial Distribution

  • 00650551080862 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110-64-061-NS

  • Cortical electrode

CORTAC® - 00650551080879

SUBDURAL GRID ELECTRODE, PLATINUM, 64 CONTACT, 8X8, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 4 EXITS, 4 LEADS, 4 TAILS, ALL CONTACTS NUMBERED
PMT CORPORATION
2110TX-64-061-NS
In Commercial Distribution

  • 00650551080879 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110TX-64-061-NS

  • Cortical electrode

CorTemp - 00857414006018

A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 300 kHz frequency and transmits via near field magnetic link..
H Q, INC
HT150031
In Commercial Distribution

  • 00857414006018 ()


  • Temperature telemetric monitoring system transmitter

CorTemp - 00857414006001

A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 262 kHz frequency and transmits via near field magnetic link.
H Q, INC
HT150002
In Commercial Distribution

  • 00857414006001 ()


  • Temperature telemetric monitoring system transmitter

Copioumed - 04719882250897

Copioumed's surgical drape can effectively block the penetration of bodily fluids during surgery, prevent cross-infection, and maintain a sterile field at the surgical site.
COPIOUMED INTERNATIONAL INC.
SDS0B101-1
In Commercial Distribution

  • 04719882250897 ()
  • 14719882250894 ()


  • Patient surgical drape, single-use

AED Battery Exchange - 00864312000253

Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A,, 9300E, 9390A, 9390E and Burdick Cardiovive AT (TM). Color White.
AED BATTERY EXCHANGE, LLC
9146-W-ABE
In Commercial Distribution

  • 00864312000253 ()


  • Primary battery

AED Battery Exchange - 00864312000239

Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, and Burdick Cardiovive AT (TM). Color Yellow.
AED BATTERY EXCHANGE, LLC
9146-Y-ABE
In Commercial Distribution

  • 00864312000239 ()


  • Primary battery

BR Surgical, LLC - 00857556008376

LED Headlight, wireless, with variable spot 20mm-110mm at 16", deluxe headband with crown and cranial support, includes 2 rechargeable lithium ion battery and charger
BR Surgical, LLC
BR900-3191
In Commercial Distribution

  • 00857556008376 ()
BR900-3191

  • Head-worn lamp
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