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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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VSI Torque Device - M20681810

The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Vascular Solutions, Inc.
8181
Not in Commercial Distribution

  • M20681810 ()
  • M20681811 ()


  • Torque manipulation device

Angio Assist™ docking station - M20681510

The AngioAssist Docking Station is intended to stabilize and load guidewires and catheters during percutaneous procedures.
Vascular Solutions, Inc.
8151
Not in Commercial Distribution

  • M20681511 ()
  • M20681510 ()


  • Medical device rail

Teirstein Edge™ device organizer - M20681500

The Teirstein Edge Device Organizer is intended to stabilize and load guidewires and catheters during percutaneous procedures.
Vascular Solutions, Inc.
8150
Not in Commercial Distribution

  • M20681501 ()
  • M20681500 ()


  • Medical device rail

VSI StraitSet™ micro-introducer kit - M20679600

No Description
Vascular Solutions, Inc.
7960
Not in Commercial Distribution

  • M20679600 ()
  • M20679601 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 6 French


  • Vascular catheter introduction set, nonimplantable

GrebSet® micro-introducer kit - M20679520

The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7952
Not in Commercial Distribution

  • M20679520 ()
  • M20679521 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

GrebSet® micro-introducer kit - M20679510

The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7951
Not in Commercial Distribution

  • M20679511 ()
  • M20679510 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

GrebSet® micro-introducer kit - M20679500

The GrebSet micro-introducer kit is indicated for use in percutaneous introduction and placement of catheters and guidewires.
Vascular Solutions, Inc.
7950
Not in Commercial Distribution

  • M20679501 ()
  • M20679500 ()

  • Catheter Gauge: 5 French
  • Needle Gauge: 21 Gauge


  • Vascular catheter introduction set, nonimplantable

GrebSet® micro-introducer kit - M20679410

No Description
Vascular Solutions, Inc.
7941
Not in Commercial Distribution

  • M20679410 ()
  • M20679411 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 5 French


  • Vascular catheter introduction set, nonimplantable

SmartNeedle® vascular access system - M206781300

Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Vascular Solutions, Inc.
78130
Not in Commercial Distribution

  • M206781301 ()
  • M206781300 ()

  • Needle Gauge: 22 Gauge


  • Noninvasive vascular ultrasound system

SmartNeedle® vascular access system - M206781200

Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Vascular Solutions, Inc.
78120
Not in Commercial Distribution

  • M206781201 ()
  • M206781200 ()

  • Needle Gauge: 24 Gauge


  • Noninvasive vascular ultrasound system

SmartNeedle® vascular access system - M206781100

Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Vascular Solutions, Inc.
78110
Not in Commercial Distribution

  • M206781101 ()
  • M206781100 ()

  • Needle Gauge: 26 Gauge


  • Noninvasive vascular ultrasound system

SmartNeedle® vascular access system - M206780600

Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Vascular Solutions, Inc.
78060
In Commercial Distribution

  • M206780601 ()
  • M206780600 ()

  • Needle Gauge: 18 Gauge


  • Noninvasive vascular ultrasound system

SmartNeedle® vascular access system - M206780500

Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Vascular Solutions, Inc.
78050
In Commercial Distribution

  • M206780501 ()
  • M206780500 ()

  • Needle Gauge: 18 Gauge


  • Noninvasive vascular ultrasound system

SmartNeedle® vascular access system - M206780400

Use of the SmartNeedle device is indicated when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and/or catheter of this size or larger.
Vascular Solutions, Inc.
78040
In Commercial Distribution

  • M206780400 ()
  • M206780401 ()

  • Needle Gauge: 20 Gauge


  • Noninvasive vascular ultrasound system

SmartNeedle® vascular access system - M206780300

No Description
Vascular Solutions, Inc.
78030
In Commercial Distribution

  • M206780300 ()
  • M206780301 ()

  • Needle Gauge: 22 Gauge


  • Noninvasive vascular ultrasound system

Disposable Vein Hook - M20678000

The Disposable Vein Hook is intended for single patient use for the treatment of superficial varicose veins and varicosities associated with superficial reflux and incompetence of the Great Saphenous Vein in the lower extremities.
Vascular Solutions, Inc.
7800
Not in Commercial Distribution

  • M20678000 ()
  • M20678001 ()


  • Vein stripper, single-use

CUSTOMED - M20890046951

ICE BAG WITH CLOSE CLAMP WHITE, LARGE
CUSTOMED INC
712057014695
In Commercial Distribution

  • M20890046952 ()
  • M20890046951 ()
  • M20890046950 ()

  • Large
9004695

  • Ice bag

CUSTOMED - M20890046941

ICE BAG WITH CLOSE CLAMP WHITE, SMALL
CUSTOMED INC
712057014694
In Commercial Distribution

  • M20890046942 ()
  • M20890046941 ()
  • M20890046940 ()

  • Small
9004694

  • Ice bag

CUSTOMED - M2089004051C1

CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES X-LARGE POWDER FREE CHEMOTHERAPY DRUG TESTED
CUSTOMED INC
712057700051
In Commercial Distribution

  • M2089004051C2 ()
  • M2089004051C1 ()
  • M2089004051C0 ()

  • X-LARGE
9004051C

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

CUSTOMED - M2089004050C1

CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES LARGE POWDER FREE CHEMOTHERAPY DRUG TESTED
CUSTOMED INC
712057700050
In Commercial Distribution

  • M2089004050C2 ()
  • M2089004050C1 ()
  • M2089004050C0 ()

  • LARGE
9004050C

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

CUSTOMED - M2089004049C1

CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES MEDIUM POWDER FREE CHEMOTHERAPY DRUG TESTED
CUSTOMED INC
712057700049
In Commercial Distribution

  • M2089004049C2 ()
  • M2089004049C1 ()
  • M2089004049C0 ()

  • MEDIUM
9004049C

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

CUSTOMED - M2089004048C1

CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES SMALL POWDER FREE CHEMOTHERAPY DRUG TESTED
CUSTOMED INC
712057700048
In Commercial Distribution

  • M2089004048C2 ()
  • M2089004048C1 ()
  • M2089004048C0 ()

  • SMALL
9004048C

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

CUSTOMED - M20890031060

NEBULIZER SET 6CC (ML) W/PEDIATRIC MASK
CUSTOMED INC
712057143106
In Commercial Distribution

  • M20890031060 ()
  • M20890031062 ()

  • Total Volume: 6 Milliliter
9003106

  • Nebulizing system delivery set, single-use

CUSTOMED - M20890031050

NEBULIZER SET 6CC (ML) W/ADULT MASK AND STANDARD CONNECTOR
CUSTOMED INC
712057143105
In Commercial Distribution

  • M20890031050 ()
  • M20890031052 ()

  • Total Volume: 6 Milliliter
9003105

  • Nebulizing system delivery set, single-use

CUSTOMED - M20890027843

DISPOSABLE VAGINAL SPECULUM LARGE
CUSTOMED INC
712057712784
In Commercial Distribution

  • M20890027843 ()
  • M20890027840 ()
  • M20890027842 ()

  • LARGE
9002784

  • Vaginal speculum, single-use

CUSTOMED - M20890027833

DISPOSABLE VAGINAL SPECULUM MEDIUM
CUSTOMED INC
712057712783
In Commercial Distribution

  • M20890027833 ()
  • M20890027830 ()
  • M20890027832 ()

  • MEDIUM
9002783

  • Vaginal speculum, single-use

CUSTOMED - M20890027823

DISPOSABLE VAGINAL SPECULUM SMALL
CUSTOMED INC
712057712782
In Commercial Distribution

  • M20890027823 ()
  • M20890027820 ()
  • M20890027822 ()

  • SMALL
9002782

  • Vaginal speculum, single-use

CUSTOMED - M20890027810

DISPOSABLE MUCUS TRAP, 80 ML (CC)
CUSTOMED INC
712057052781
In Commercial Distribution

  • M20890027812 ()
  • M20890027810 ()

  • Total Volume: 80 Milliliter
9002781

  • Sputum specimen container IVD

CUSTOMED - M20890027800

DISPOSABLE MUCUS TRAP, 40 ML (CC)
CUSTOMED INC
712057052780
In Commercial Distribution

  • M20890027800 ()
  • M20890027802 ()

  • Total Volume: 40 Milliliter
9002780

  • Sputum specimen container IVD

CUSTOMED - M20890025016600

CUSTOMED I-MAX ASPIRATION TIP BIOPSY NEEDLE, 16G X 60MM, WHITE
CUSTOMED INC
712057831660
In Commercial Distribution

  • M20890025016600 ()
  • M20890025016601 ()

  • Length: 60 Millimeter
  • Needle Gauge: 16 Gauge
9002501660

  • Bone marrow biopsy needle, single-use

CUSTOMED - M20890025016500

CUSTOMED I-MAX ASPIRATION TIP BIOPSY NEEDLE, 16G X 50MM, WHITE
CUSTOMED INC
712057831650
In Commercial Distribution

  • M20890025016500 ()
  • M20890025016501 ()

  • Length: 50 Millimeter
  • Needle Gauge: 16 Gauge
9002501650

  • Bone marrow biopsy needle, single-use

CUSTOMED - M20890022201

SURGICAL MASK BLUE, VISOR, ANTI-FOG, AQUA WITH TIES, 160MM HG
CUSTOMED INC
712057462220
In Commercial Distribution

  • M20890022201 ()
  • M20890022200 ()
  • M20890022202 ()

  • LEVEL 3 BARRIER PROTECTION 160 MM HG
9002220

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022191

SURGICAL MASK, SOFT, WHITE, WITH TIES, 120MM HG
CUSTOMED INC
712057462219
In Commercial Distribution

  • M20890022191 ()
  • M20890022190 ()
  • M20890022192 ()

  • LEVEL 2 BARRIER PROTECTION 120 MM HG
9002219

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022181

SURGICAL MASK, BLUE, WITH TIES, 80MM HG
CUSTOMED INC
712057462218
In Commercial Distribution

  • M20890022181 ()
  • M20890022180 ()
  • M20890022182 ()

  • LEVEL 1 BARRIER PROTECTION 80 MM HG
9002218

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022171

SURGICAL MASK, BLUE, WITH TIES, 120 MM HG
CUSTOMED INC
712057462217
In Commercial Distribution

  • M20890022171 ()
  • M20890022170 ()
  • M20890022172 ()

  • LEVEL 2 BARRIER PROTECTION 120 MM HG
9002217

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022161

SURGICAL MASK, BLUE, WITH TIES, 80MM HG
CUSTOMED INC
712057462216
In Commercial Distribution

  • M20890022161 ()
  • M20890022160 ()
  • M20890022162 ()

  • LEVEL 1 BARRIER PROTECTION 80MM HG
9002216

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022151

PROCEDURE MASK, VISOR, ANTI-FOG, AQUA WITH EAR LOOPS, 160MM HG
CUSTOMED INC
712057462215
In Commercial Distribution

  • M20890022151 ()
  • M20890022150 ()
  • M20890022152 ()

  • LEVEL 3 BARRIER PROTECTION 160 MM HG
9002215

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022141

PROCEDURE MASK, YELLOW, EAR LOOP, 80MM HG
CUSTOMED INC
712057462214
In Commercial Distribution

  • M20890022141 ()
  • M20890022140 ()
  • M20890022142 ()

  • LEVEL 1 BARRIER PROTECTION 80 MM HG
9002214

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022131

SURGICAL MASK, ANTI-FOG ADHESIVE TAPE, GREEN 80MM HG
CUSTOMED INC
712057462213
In Commercial Distribution

  • M20890022131 ()
  • M20890022130 ()
  • M20890022132 ()

  • LEVEL 1 BARRIER PROTECTION 80 MM HG
9002213

  • Surgical/medical face mask, single-use

CUSTOMED - M20890022011150

CUSTOMED J-MAX DIAMOND TIP BIOPSY NEEDLE, 11G X 150MM, WHITE
CUSTOMED INC
712057831115
In Commercial Distribution

  • M20890022011150 ()
  • M20890022011151 ()

  • Length: 150 Millimeter
  • Needle Gauge: 11 Gauge
9002201115

  • Bone marrow biopsy needle, single-use
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