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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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Easy Glide INSULIN SYRIN 0.3 ML 30GX5/16" 1/2 UNIT MARKING - B2086345630

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 - B2086345030

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 - B2086325630

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" - B2086315650

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" - B2086315630

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" - B2086315610

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" - B2086305650

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" - B2086305630

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" - B2086305610

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" - B2086305050

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" - B2086305030

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" - B2086305010

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" - B2086295050

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" - B2086295030

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" - B2086295010

Easy Glide INSULIN SYRINGE 1 ML 29GX1/2"
GLOBAL DIABETIC DISTRIBUTORS INC
629501
In Commercial Distribution

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


  • Insulin syringe/needle, basic

BIA Electrodes - B202925001

Package contains 100 adhesive electrodes, sufficient for performing 25 BIA tests for whole-body body composition analysis.
R.J.L. SCIENCES, INC.
92500
In Commercial Distribution

  • B202925004 ()
  • B202925003 ()
  • B202925001 ()
  • B202925002 ()
  • B20292500 ()
92500P

  • Electrocardiographic electrode, single-use

Clear Guide VisiMARKER Non-Sterile - B201CGVMNS0

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.
CGVMNS
In Commercial Distribution

  • B201CGVMNS0 ()
  • B201CGVMNS1 ()
  • B201CGVMNS3 ()
  • B201CGVMNS2 ()
CG-VM-NS

  • Imaging lesion localization marker, external, single-use

Clear Guide VisiMARKER II Non-Sterile - B201CGVM2NS0

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

Clear Guide VisiMARKER II - B201CGVM20

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

Clear Guide VisiMARKER - B201CGVM0

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

Environ-mate - B325PT20C101

Polyp Trap with screw top, fine-mesh screen and tube with connector.. Package of 10.
M D Technologies Inc.
PT20C-10
In Commercial Distribution

  • B325PT20C100 ()
  • B325PT20C101 ()
  • B325PT20C252 ()
  • B325PT20C503 ()
  • B325PT20C1004 ()
PT20C10

  • Surgical suction system collection container, single-use

Environ-mate - B325PT20101

Polyp Trap with screw top, fine-mesh screen and plain tube. Package of 10.
M D Technologies Inc.
PT20-10
In Commercial Distribution

  • B325PT20252 ()
  • B325PT20100 ()
  • B325PT20503 ()
  • B325PT201004 ()
  • B325PT20101 ()
PT2010

  • Surgical suction system collection container, single-use

PURE ENRICHMENT - B311PEPADBFLY0

LARGE ELECTRODE PAD
BEAR DOWN CONSULTING
PEPADBFLY
In Commercial Distribution

  • B311PEPADBFLY1 ()
  • B311PEPADBFLY0 ()
  • B311PEPADBFLY2 ()
  • B311PEPADBFLY3 ()


  • Transcutaneous electrical stimulation electrode, single-use

Flo2Max Oxygen Mask, Child - B00261100

Flo2Max 5-in-1 Oxygen Mask, Child
B.L.S. Systems Limited
6110
In Commercial Distribution

  • B00266107 ()
  • B00261100 ()
  • B00261109 ()
  • B00261107 ()

  • Child
6110

  • Non-rebreathing oxygen face mask

S-CRYOLOCK (Y) - B056SCLY1

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 (O) - B056SCLO1

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 (G) - B056SCLG1

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 (C) - B056SCLC1

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 (B) - B056SCLB1

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

Cardiva VASCADE MVP XL VVCS 10-12F - M7298001012XL0

The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-1012XL
In Commercial Distribution

  • M7298001012XL2 ()
  • M7298001012XL0 ()
  • M7298001012XL1 ()
  • M7298001012XL3 ()

  • Catheter Gauge: 10 to 12 French


  • Femoral artery closure plug/patch, collagen

ResQCPR System - M5921208250001

The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution

  • M5921208220000 ()
  • M5921208250001 ()
  • M5921208230001 ()


  • Cardiac resuscitator, manual

ResQPOD ITD 10 - M5921202420000

The ResQPOD ITD 10 is indicated for the temporary increase in blood circulation.
ADVANCED CIRCULATORY SYSTEMS INC
12-0242-000
In Commercial Distribution

  • M5921202420000 ()
  • M5921202420001 ()
  • M5921202420002 ()


  • Cardiopulmonary resuscitation impedance valve, inspiratory

Sutrasilk - M583VS840821

8-0 Suture USP / Thread Specifications: Silk, Virgin, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula tip, 3/8 circle (140 degrees), length 6.0 mm, wire 0.20mm / # of needles: double arm
VISIONARY MEDICAL SUPPLIES INC
VS84082
In Commercial Distribution

  • M583VS840823 ()
  • M583VS840822 ()
  • M583VS840821 ()

  • Angle: 140 degree
  • 8-0 USP
  • Outer Diameter: 0.20 Millimeter
  • Length: 6.0 Millimeter
  • Length: 40 Centimeter


  • Silk suture

Sutrasilk - M583VS840811

8-0 Suture USP / Thread Specifications: Silk, Virgin, 16 inch (40 cm) / Needle Specifications: ST-140-8, Spatula tip, 3/8 circle (140 degrees), length 6.0 mm, wire 0.20mm / # of needles: single arm
VISIONARY MEDICAL SUPPLIES INC
VS84081
In Commercial Distribution

  • M583VS840813 ()
  • M583VS840812 ()
  • M583VS840811 ()

  • Length: 40 Centimeter
  • Length: 6.0 Millimeter
  • Outer Diameter: 0.20 Millimeter
  • 8-0 USP
  • Angle: 140 degree


  • Silk suture

Sutrasilk - M583S840821

8-0 Suture USP / Thread Specifications: Silk, Black Braided, 12 inch (30 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 circle (140 degrees), length 6 mm, wire 0.20mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S84082
In Commercial Distribution

  • M583S840823 ()
  • M583S840822 ()
  • M583S840821 ()

  • Angle: 140 degree
  • 8-0 USP
  • Outer Diameter: 0.20 Millimeter
  • Length: 6.0 Millimeter
  • Length: 30 Centimeter


  • Silk suture

Sutrasilk - M583S74092TP1

7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: TP-140-9, Taper Point, 3/8 circle (140 degrees), length 9.0 mm, wire 0.23mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S74092TP
In Commercial Distribution

  • M583S74092TP3 ()
  • M583S74092TP2 ()
  • M583S74092TP1 ()

  • Angle: 140 degree
  • 7-0 USP
  • Outer Diameter: 0.23 Millimeter
  • Length: 9.0 Millimeter
  • Length: 45 Centimeter


  • Silk suture

Sutrasilk - M583S740921

7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: ST-140-9, Spatula Tip, 3/8 circle (140 degrees), length 6.6 mm, wire 0.23mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S74092
In Commercial Distribution

  • M583S740923 ()
  • M583S740922 ()
  • M583S740921 ()

  • Angle: 140 degree
  • Length: 45 Centimeter
  • Length: 6.6 Millimeter
  • Outer Diameter: 0.23 Millimeter
  • 7-0 USP


  • Silk suture

Sutrasilk - M583S6401121

6-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: ST-140-11, Spatula Tip, 3/8 circle (140 degrees), length 8.0 mm, wire 0.28mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S640112
In Commercial Distribution

  • M583S6401123 ()
  • M583S6401122 ()
  • M583S6401121 ()

  • Angle: 140 degree
  • 6-0 USP
  • Outer Diameter: 0.28 Millimeter
  • Length: 8.0 Millimeter
  • Length: 76 Centimeter


  • Silk suture

Sutrasilk - M583S440171C1

4-0 Suture USP / Thread Specifications: Silk, Black Braided, 30 inch (76 cm) / Needle Specifications: CT-135-17, Cutting Tip, 3/8 circle (140 degrees), length 15.9 mm, wire 0.43mm / # of needles: Single arm
VISIONARY MEDICAL SUPPLIES INC
S440171C
In Commercial Distribution

  • M583S440171C3 ()
  • M583S440171C2 ()
  • M583S440171C1 ()

  • Angle: 140 degree
  • 4-0 USP
  • Outer Diameter: 0.43 Millimeter
  • Length: 15.9 Millimeter
  • Length: 76 Centimeter


  • Silk suture

Sutralene - M583P990621

9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-90-6, Spatula Tip, ¼ circle (90 degrees), length 16 mm, wire 0.15 mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
P99062
In Commercial Distribution

  • M583P990623 ()
  • M583P990622 ()
  • M583P990621 ()

  • Angle: 90 degree
  • 9-0 USP
  • Outer Diameter: 0.15 Millimeter
  • Length: 16 Millimeter
  • Length: 30 Centimeter


  • Polyolefin/fluoropolymer suture, monofilament
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