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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The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM2NS
In Commercial Distribution

  • B201CGVM2NS0 ()
  • B201CGVM2NS1 ()
  • B201CGVM2NS3 ()
  • B201CGVM2NS2 ()
CG-VM2-NS

  • Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM2
In Commercial Distribution

  • B201CGVM20 ()
  • B201CGVM21 ()
  • B201CGVM23 ()
  • B201CGVM22 ()
CG-VM2

  • Imaging lesion localization marker, external, single-use
The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM
In Commercial Distribution

  • B201CGVM2 ()
  • B201CGVM1 ()
  • B201CGVM0 ()
  • B201CGVM3 ()


  • Imaging lesion localization marker, external, single-use
Easy Glide 3cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
673030
In Commercial Distribution

  • B2086730303 ()
  • B2086730301 ()
  • B2086730300 ()
  • B2086730304 ()


  • General-purpose syringe, single-use
Easy Glide 10cc Luer Lock Syringe
GLOBAL DIABETIC DISTRIBUTORS INC
671020
In Commercial Distribution

  • B2086710203 ()
  • B2086710201 ()
  • B2086710200 ()
  • B2086710204 ()


  • General-purpose syringe, single-use
Easy Glide Pen Needle 31G X 5/16" (8mm)
GLOBAL DIABETIC DISTRIBUTORS INC
668315
In Commercial Distribution

  • B2086683153 ()
  • B2086683152 ()
  • B2086683151 ()
  • B2086683150 ()


  • Autoinjector needle
Easy Glide Pen Needle 31G X 3/16" (5mm)
GLOBAL DIABETIC DISTRIBUTORS INC
666313
In Commercial Distribution

  • B2086663133 ()
  • B2086663132 ()
  • B2086663131 ()
  • B2086663130 ()


  • Autoinjector needle
Easy Glide Pen Needle 32G X 5/32" (4mm)
GLOBAL DIABETIC DISTRIBUTORS INC
664315
In Commercial Distribution

  • B2086643153 ()
  • B2086643152 ()
  • B2086643151 ()
  • B2086643150 ()


  • Autoinjector needle
Easy Glide Pen Needle 33G X 5/32" (4mm)
GLOBAL DIABETIC DISTRIBUTORS INC
663304
In Commercial Distribution

  • B2086633040 ()
  • B2086633041 ()
  • B2086633042 ()
  • B2086633043 ()


  • Autoinjector needle
Easy Glide Pen Needle 29G X 1/2" (12mm)
GLOBAL DIABETIC DISTRIBUTORS INC
661212
In Commercial Distribution

  • B2086612123 ()
  • B2086612122 ()
  • B2086612121 ()
  • B2086612120 ()


  • Autoinjector needle
Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT MARKING
GLOBAL DIABETIC DISTRIBUTORS INC
634563
In Commercial Distribution

  • B2086345633 ()
  • B2086345632 ()
  • B2086345631 ()
  • B2086345630 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.3 ML 30GX1/2" 1/2 UNIT MARKING
GLOBAL DIABETIC DISTRIBUTORS INC
634503
In Commercial Distribution

  • B2086345033 ()
  • B2086345032 ()
  • B2086345031 ()
  • B2086345030 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRINGE .3ML 31GX5/16" 1/2 UNIT MARKING
GLOBAL DIABETIC DISTRIBUTORS INC
632563
In Commercial Distribution

  • B2086325633 ()
  • B2086325632 ()
  • B2086325631 ()
  • B2086325630 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.5 ML 31GX5/16"
GLOBAL DIABETIC DISTRIBUTORS INC
631565
In Commercial Distribution

  • B2086315653 ()
  • B2086315652 ()
  • B2086315651 ()
  • B2086315650 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.3 ML 31GX5/16"
GLOBAL DIABETIC DISTRIBUTORS INC
631563
In Commercial Distribution

  • B2086315633 ()
  • B2086315632 ()
  • B2086315631 ()
  • B2086315630 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRINGE 1 ML 31GX5/16"
GLOBAL DIABETIC DISTRIBUTORS INC
631561
In Commercial Distribution

  • B2086315613 ()
  • B2086315612 ()
  • B2086315611 ()
  • B2086315610 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.5 ML 30GX5/16"
GLOBAL DIABETIC DISTRIBUTORS INC
630565
In Commercial Distribution

  • B2086305653 ()
  • B2086305652 ()
  • B2086305651 ()
  • B2086305650 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16"
GLOBAL DIABETIC DISTRIBUTORS INC
630563
In Commercial Distribution

  • B2086305633 ()
  • B2086305632 ()
  • B2086305631 ()
  • B2086305630 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRINGE 1 ML 30GX5/16"
GLOBAL DIABETIC DISTRIBUTORS INC
630561
In Commercial Distribution

  • B2086305613 ()
  • B2086305612 ()
  • B2086305611 ()
  • B2086305610 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.5 ML 30GX1/2"
GLOBAL DIABETIC DISTRIBUTORS INC
630505
In Commercial Distribution

  • B2086305053 ()
  • B2086305052 ()
  • B2086305051 ()
  • B2086305050 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.3 ML 30GX1/2"
GLOBAL DIABETIC DISTRIBUTORS INC
630503
In Commercial Distribution

  • B2086305033 ()
  • B2086305032 ()
  • B2086305031 ()
  • B2086305030 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRINGE 1 ML 30GX1/2"
GLOBAL DIABETIC DISTRIBUTORS INC
630501
In Commercial Distribution

  • B2086305013 ()
  • B2086305012 ()
  • B2086305011 ()
  • B2086305010 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.5 ML 29GX1/2"
GLOBAL DIABETIC DISTRIBUTORS INC
629505
In Commercial Distribution

  • B2086295053 ()
  • B2086295052 ()
  • B2086295051 ()
  • B2086295050 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRIN 0.3 ML 29GX1/2"
GLOBAL DIABETIC DISTRIBUTORS INC
629503
In Commercial Distribution

  • B2086295030 ()
  • B2086295031 ()
  • B2086295032 ()
  • B2086295033 ()


  • Insulin syringe/needle, basic
Easy Glide INSULIN SYRINGE 1 ML 29GX1/2"
GLOBAL DIABETIC DISTRIBUTORS INC
629501
In Commercial Distribution

  • B2086295013 ()
  • B2086295012 ()
  • B2086295011 ()
  • B2086295010 ()


  • Insulin syringe/needle, basic
ProVeil™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeil™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
PV4030
In Commercial Distribution

  • B130PV40301 ()
  • B130PV40300 ()
  • B130PV40302 ()
  • B130PV40303 ()
PV4030

  • Nerve guide, animal-derived
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS4030
In Commercial Distribution

  • B130NS40300 ()
  • B130NS40301 ()
  • B130NS40302 ()
  • B130NS40303 ()
NS4030

  • Nerve guide, animal-derived
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS3020
In Commercial Distribution

  • B130NS30201 ()
  • B130NS30200 ()
  • B130NS30202 ()
  • B130NS30203 ()
NS3020

  • Nerve guide, animal-derived
The Guardian Intraoperative Lead is a single-use, sterile medical device accessory consisting of an electrode for contacting nerve, a lead wire and a connector. The connector securely connects to a Checkpoint intraoperative stimulator to provide electrical stimulation of exposed motor nerves or muscle tissue. The Small size has lead body width of approximately 4mm.
Checkpoint Surgical, Inc.
9524
In Commercial Distribution

  • B13095241 ()
  • B13095240 ()
  • B13095242 ()
  • B13095243 ()

  • Width: 4 Millimeter
9524

  • Nerve-locating system
Probe Extension, 4 cm for use with Checkpoint Stimulators`
Checkpoint Surgical, Inc.
9506
In Commercial Distribution

  • B13095061 ()
  • B13095060 ()
  • B13095062 ()
  • B13095063 ()
9506

  • Nerve-locating system
Probe Extension with Ball Tip, 12 cm for use with Checkpoint Stimulators
Checkpoint Surgical, Inc.
9505
In Commercial Distribution

  • B13095051 ()
  • B13095050 ()
  • B13095052 ()
  • B13095053 ()
9505

  • Nerve-locating system
Probe Extension, 12 cm for use with Checkpoint Stimulators
Checkpoint Surgical, Inc.
9504
In Commercial Distribution

  • B13095041 ()
  • B13095040 ()
  • B13095042 ()
  • B13095043 ()
9504

  • Nerve-locating system
The CHECKPOINT EDGE™ Nerve Cutting Kit is a single-use, sterile kit intended to provide surgeon aid in transecting nerve tissue for the purpose of nerve graft preparation, nerve repair, or removal of exposed nerve. The kit includes three circumferential nerve constraining forceps, two blades, and a silicone visibility background.
Checkpoint Surgical, Inc.
9250
In Commercial Distribution

  • B13092501 ()
  • B13092500 ()
  • B13092502 ()
  • B13092503 ()
9250

  • Surgical soft-tissue manipulation forceps, tweezers-like, single-use
Handheld Single-use Surgical Nerve Stimulator
Checkpoint Surgical, Inc.
9095
In Commercial Distribution

  • B13090951 ()
  • B13090950 ()
  • B13090952 ()
  • B13090953 ()
9095

  • Nerve-locating system
Handheld Single-use Surgical Bipolar Nerve Stimulator
Checkpoint Surgical, Inc.
9092
In Commercial Distribution

  • B13090921 ()
  • B13090920 ()
  • B13090922 ()
  • B13090923 ()
9092

  • Nerve-locating system
S-CRYOLOCK - YELLOW - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (Y)
In Commercial Distribution

  • B056SCLY5 ()
  • B056SCLY2 ()
  • B056SCLY1 ()
  • B056SCLY0 ()
  • B056SCLY3 ()
S-CL (YELLOW)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (O)
In Commercial Distribution

  • B056SCLO5 ()
  • B056SCLO2 ()
  • B056SCLO1 ()
  • B056SCLO0 ()
  • B056SCLO3 ()
S-CL (ORANGE)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - GREEN - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (G)
In Commercial Distribution

  • B056SCLG5 ()
  • B056SCLG2 ()
  • B056SCLG1 ()
  • B056SCLG0 ()
  • B056SCLG3 ()
S-CL (GREEN)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (C)
In Commercial Distribution

  • B056SCLC5 ()
  • B056SCLC2 ()
  • B056SCLC1 ()
  • B056SCLC0 ()
  • B056SCLC3 ()
S-CL (CLEAR)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - BLUE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (B)
In Commercial Distribution

  • B056SCLB5 ()
  • B056SCLB2 ()
  • B056SCLB1 ()
  • B056SCLB0 ()
  • B056SCLB3 ()
S-CL (BLUE)

  • Assisted reproduction vitrification carrier
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