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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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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
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
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
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
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
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
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 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 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 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 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 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
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™ 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™ 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™ 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
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
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
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
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
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
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
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'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
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
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
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
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
In Commercial Distribution

  • 00650551051312 ()

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

  • Cortical electrode
Akahoshi-Tjia MICS Capsularhexis Forceps Round Handle, Special Alignment Mechanism for Incisions as Small as 1.8mm. Triangular Tips, Laser Lines at 1mm Increments, Vaulted Shafts
Med Saver, Inc.
15-5455-VR
In Commercial Distribution

  • 00194613119270 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
Seven Step Trifacet Diamond Knife Black Titanium Handle Design Small Single Footplate. 7 Preset Steps at 0.30, 0.40, 0.50, 0.60, 0.80, 1.00 & 2.50 mm
Med Saver, Inc.
813
In Commercial Distribution

  • 00194613046262 ()


  • Ophthalmic knife, reusable
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