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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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25ga Curved Laser Probe - Alcon Compatible - B384VS012025A1

25ga Curved Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS120.25A
In Commercial Distribution

  • B384VS012025A5 ()
  • B384VS012025A1 ()

  • Needle Gauge: 25 Gauge
VS120.25A

  • Ophthalmic laser system beam guide

20ga Curved Laser Probe - Alcon Compatible - B384VS012020A1

20ga Curved Laser Probe- Alcon Compatible
Vortex Surgical, Inc.
VS0120.20A
In Commercial Distribution

  • B384VS012020A5 ()
  • B384VS012020A1 ()

  • Needle Gauge: 20 Gauge
VS0120.20A

  • Ophthalmic laser system beam guide

23ga Straight Laser Probe - Alcon Compatible - B384VS011023A1

23ga Straight Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0110.23A
In Commercial Distribution

  • B384VS011023A5 ()
  • B384VS011023A1 ()

  • Needle Gauge: 23 Gauge
VS0110.25A

  • Ophthalmic laser system beam guide

Accurett - B386SCO216GBOX1

No Description
H & O Equipments SA
16g CO2 cartridges
In Commercial Distribution

  • B386SCO216GCARTON2 ()
  • B386SCO216GBOX1 ()
  • B386SCO216GBOX0 ()
S-CO2-16G-BOX

  • Carbon dioxide cartridge, non-sterile

Freezpen® - B386CLN2O8GUNBOX1

No Description
H & O Equipments SA
8g cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O8GUNCARTON2 ()
  • B386CLN2O8GUNBOX1 ()
  • B386CLN2O8GUNBOX0 ()
CL-N2O-8G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

25ga Flexible Tapered Laser Probe - Alcon Compatible - B384VS013025A1

25ga Flexible Tapered Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0130.25A
In Commercial Distribution

  • B384VS013025A5 ()
  • B384VS013025A1 ()

  • Needle Gauge: 25 Gauge
VS0130.25A

  • Ophthalmic laser system beam guide

23ga Flexible Tapered Laser Probe - Iridex Compatible - B384VS013023I1

23ga Flexible Tapered Laser Probe - Iridex Compatible
Vortex Surgical, Inc.
VS0130.23I
In Commercial Distribution

  • B384VS013023I5 ()
  • B384VS013023I1 ()

  • Needle Gauge: 23 Gauge
VS0130.23I

  • Ophthalmic laser system beam guide

23ga Flexible Tapered Laser Probe - Alcon Compatible - B384VS013023A1

23ga Flexible Tapered Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0130.23A
In Commercial Distribution

  • B384VS013023A5 ()
  • B384VS013023A1 ()

  • Needle Gauge: 23 Gauge
VS0130.23A

  • Ophthalmic laser system beam guide

20ga Flexible Tapered Laser Probe - Alcon Compatible - B384VS013020A1

20ga Flexible Tapered Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0130.20A
In Commercial Distribution

  • B384VS013020A5 ()
  • B384VS013020A1 ()

  • Needle Gauge: 20 Gauge
VS0130.20A

  • Ophthalmic laser system beam guide

25ga Straight Laser Probe - Alcon Compatible - B384VS011025A1

25ga Straight Laser Probe - Alcon Compatible
Vortex Surgical, Inc.
VS0110.25A
In Commercial Distribution

  • B384VS011025A5 ()
  • B384VS011025A1 ()

  • Needle Gauge: 25 Gauge
VS0110.25A

  • Ophthalmic laser system beam guide

20ga Straight Laser Probe - Alcon compatible - B384VS011020A1

20ga Straight Laser Probe - Alcon compatible
Vortex Surgical, Inc.
VS0110.20A
In Commercial Distribution

  • B384VS011020A5 ()
  • B384VS011020A1 ()

  • Needle Gauge: 20 Gauge
VS0110.20A

  • Ophthalmic laser system beam guide

SkinGard Nitrile Examination Gloves - TQ261101

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size S
TOP QUALITY MANUFACTURING, INC.
110
In Commercial Distribution

  • TQ261102 ()
  • TQ261101 ()
  • TQ261100 ()
110

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

Periwinkle Nitrile Examination Gloves - TQ2610301

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size XL
TOP QUALITY MANUFACTURING, INC.
1030
In Commercial Distribution

  • TQ2610302 ()
  • TQ2610301 ()
  • TQ2610300 ()
1030

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

Periwinkle Nitrile Examination Gloves - TQ2610291

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size L
TOP QUALITY MANUFACTURING, INC.
1029
In Commercial Distribution

  • TQ2610292 ()
  • TQ2610291 ()
  • TQ2610290 ()
1029

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

Periwinkle Nitrile Examination Gloves - TQ2610281

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size M
TOP QUALITY MANUFACTURING, INC.
1028
In Commercial Distribution

  • TQ2610282 ()
  • TQ2610281 ()
  • TQ2610280 ()
1028

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

Periwinkle Nitrile Examination Gloves - TQ2610271

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size S
TOP QUALITY MANUFACTURING, INC.
1027
In Commercial Distribution

  • TQ2610272 ()
  • TQ2610271 ()
  • TQ2610270 ()
1027

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

Periwinkle Nitrile Examination Gloves - TQ2610261

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size XS
TOP QUALITY MANUFACTURING, INC.
1026
In Commercial Distribution

  • TQ2610262 ()
  • TQ2610261 ()
  • TQ2610260 ()
1026

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

SkinGard Nitrile Examination Gloves - TQ261001

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Blue Size XS
TOP QUALITY MANUFACTURING, INC.
100
In Commercial Distribution

  • TQ261002 ()
  • TQ261001 ()
  • TQ261000 ()
100

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

SYSTEM 83 PLUS - SYSTEM83PLUS9

A device to disinfect endoscopes
Wassenburg Medical, Inc.
SYSTEM 83 PLUS 9
Not in Commercial Distribution

  • SYSTEM83PLUS9 ()
  • B21583PLUS9 ()


  • Endoscope washer-disinfector (chemical)

SYSTEM 83 PLUS - SYSTEM83PLUS2

A device to disinfect endoscopes
Wassenburg Medical, Inc.
SYSTEM 83 PLUS 2
Not in Commercial Distribution

  • SYSTEM83PLUS2 ()
  • B21583PLUS2 ()


  • Endoscope washer-disinfector (chemical)

Storage Cabinet - STORAGECABINET20000

A device to store endoscopes.
Wassenburg Medical, Inc.
20000
Not in Commercial Distribution

  • B215STORAGECABINET20000 ()
  • STORAGECABINET20000 ()


  • Endoscope drying/storage cabinet

Shukla Acetabular Cup - S9CUP - SBLDACE52SP0

Blades, Ace Cup, 52mm, Starter & Finisher, Single Use, Sterile Packed
Shukla Medical
SBLDACE-52-SP
In Commercial Distribution

  • SBLDACE52SP1 ()
  • SBLDACE52SP0 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

Shukla Acetabular Cup - S9CUP - SBLDACE48SP0

Blades, Ace Cup, 48mm, Starter & Finisher, Single Use, Sterile Packed
Shukla Medical
SBLDACE-48-SP
In Commercial Distribution

  • SBLDACE48SP1 ()
  • SBLDACE48SP0 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

Shukla Acetabular Cup - S9CUP - SBLDACE46SP0

Blades, Ace Cup, 46mm, Starter & Finisher, Single Use, Sterile Packed
Shukla Medical
SBLDACE-46-SP
In Commercial Distribution

  • SBLDACE46SP1 ()
  • SBLDACE46SP0 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

Shukla Acetabular Cup - S9CUP - SBLDACE44SP0

Blades, Ace Cup, 44mm, Starter & Finisher, Single Use, Sterile Packed
Shukla Medical
SBLDACE-44-SP
In Commercial Distribution

  • SBLDACE44SP1 ()
  • SBLDACE44SP0 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

Shukla Acetabular Cup - S9CUP - SBLDACE42SP0

Blades, Ace Cup, 42mm, Starter & Finisher, Single Use, Sterile Packed
Shukla Medical
SBLDACE-42-SP
In Commercial Distribution

  • SBLDACE42SP1 ()
  • SBLDACE42SP0 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

Shukla Acetabular Cup - S9CUP - SBLDACE050SP0

Blades, Ace Cup, 50mm, Starter & Finisher, Single Use, Sterile Packed
Shukla Medical
SBLDACE-50-SP
In Commercial Distribution

  • SBLDACE050SP1 ()
  • SBLDACE050SP0 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use

BioFlo - PKM137544S0

PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKM137544S
In Commercial Distribution

  • H965PKM137544S1 ()
  • PKM137544S0 ()

  • Catheter Gauge: 4 French
  • Length: 55 Centimeter
  • Single


  • Peripherally-inserted central venous catheter

Kroger - MHC19301012

Kroger Twist Lancets 30g
MHC MEDICAL PRODUCTS, LLC
930101
In Commercial Distribution

  • MHC19301013 ()
  • MHC19301012 ()
  • MHC19301010 ()
930101

  • Blood lancet, single-use

Kroger Healthpro - MHC19090112

Kroger Blood Glucose Control Solution
MHC MEDICAL PRODUCTS, LLC
909011
In Commercial Distribution

  • MHC19090113 ()
  • MHC19090112 ()
909011

  • Blood glucose/blood pressure monitoring system, home-use
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