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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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Soft-Vu - H787507226300

Soft-Vu Angiographic Catheter, Cobra (2), Braided
ANGIODYNAMICS, INC.
50722630
Not in Commercial Distribution

  • H787507226305 ()
  • H787507226300 ()
  • 15051684010511 ()

  • Length: 65 Centimeter
  • Outer Diameter: 1.4 Millimeter
  • Catheter Gauge: 4 French


  • Angiographic catheter, single-use

Soft-Vu - H787507226200

Soft-Vu Angiographic Catheter, Osborne (2), Braided
ANGIODYNAMICS, INC.
50722620
Not in Commercial Distribution

  • H787507226205 ()
  • H787507226200 ()
  • 15051684010498 ()

  • Outer Diameter: 1.4 Millimeter
  • Catheter Gauge: 4 French
  • Length: 100 Centimeter


  • Angiographic catheter, single-use

Soft-Vu - H787507213010

Soft-Vu Angiographic Catheter, Simmons Sidewinder (1), Braided
ANGIODYNAMICS, INC.
50721301
In Commercial Distribution

  • H787507213015 ()
  • H787507213010 ()
  • 15051684010467 ()

  • Length: 65 Centimeter
  • Outer Diameter: 1.4 Millimeter
  • Catheter Gauge: 4 French


  • Angiographic catheter, single-use

Soft-Vu - H787507190010

Soft-Vu Angiographic Catheter, Straight, Non-Braided
ANGIODYNAMICS, INC.
50719001
In Commercial Distribution

  • H787507190015 ()
  • H787507190010 ()
  • 15051684010443 ()

  • Outer Diameter: 1.4 Millimeter
  • Length: 90 Centimeter
  • Catheter Gauge: 4 French


  • Angiographic catheter, single-use

Soft-Vu - H787507166010

Soft-Vu Angiographic Catheter, Shepherd Hook, Braided
ANGIODYNAMICS, INC.
50716601
In Commercial Distribution

  • H787507166015 ()
  • H787507166010 ()
  • 15051684010429 ()

  • Length: 65 Centimeter
  • Catheter Gauge: 4 French
  • Outer Diameter: 1.4 Millimeter


  • Angiographic catheter, single-use

Soft-Vu - H787507124010

Soft-Vu Angiographic Catheter, Levin (1), Non-Braided
ANGIODYNAMICS, INC.
50712401
In Commercial Distribution

  • H787507124015 ()
  • H787507124010 ()
  • 15051684010405 ()

  • Catheter Gauge: 4 French
  • Outer Diameter: 1.4 Millimeter
  • Length: 65 Centimeter


  • Angiographic catheter, single-use

Soft-Vu - H787507074040

Soft-Vu Angiographic Catheter, Hockey Stick (10), Braided
ANGIODYNAMICS, INC.
50707404
In Commercial Distribution

  • H787507074045 ()
  • H787507074040 ()
  • 15051684010375 ()

  • Catheter Gauge: 4 French
  • Length: 65 Centimeter
  • Outer Diameter: 1.4 Millimeter


  • Angiographic catheter, single-use

Soft-Vu - H787507023010

Soft-Vu Angiographic Catheter, Berenstein, Non-Braided
ANGIODYNAMICS, INC.
50702301
In Commercial Distribution

  • H787507023015 ()
  • H787507023010 ()
  • 15051684010337 ()

  • Catheter Gauge: 4 French
  • Outer Diameter: 1.4 Millimeter
  • Length: 65 Centimeter


  • Angiographic catheter, single-use

AngiOptic - H787506001310

AngiOptic Angiographic Catheter, Sos Omni Selective (2), Non-Braided
ANGIODYNAMICS, INC.
50600131
In Commercial Distribution

  • H787506001315 ()
  • H787506001310 ()
  • 15051684005647 ()

  • Catheter Gauge: 4 French
  • Length: 110 Centimeter


  • Angiographic catheter, single-use

Celerity - H787471420

Celerity Non-Sterile Disposable (ECG Adhesive Electrodes & Prep Pads)
NAVILYST MEDICAL, INC.
47-142
In Commercial Distribution

  • H787471420 ()
  • H787471421 ()


  • Electrocardiographic electrode, single-use

Syntrax Support Catheter - H787181800

Syntrax Support Catheter, .018" x 180cm
ANGIODYNAMICS, INC.
18-180
In Commercial Distribution

  • H787181801 ()
  • H787181800 ()
  • 15051684029568 ()

  • Catheter Gauge: 4 French
  • Length: 180 Centimeter
  • Max Guidewire OD - 0.018"


  • Vascular guide-catheter, single-use

AngioDynamics - H787181002040

Percutaneous Introducer Sheath
ANGIODYNAMICS, INC.
18100204
In Commercial Distribution

  • H787181002045 ()
  • H787181002040 ()
  • 15051684018944 ()

  • Catheter Gauge: 7 French


  • Vascular catheter introduction set, nonimplantable

VenaCure - H787165100010

Venacure EVLT NeverTouch Direct Introducer Sheath
ANGIODYNAMICS, INC.
16510001
In Commercial Distribution

  • H787165100010 ()
  • H787165100011 ()
  • 15051684014724 ()

  • Length: 10 Centimeter
  • Catheter Gauge: 4 French


  • Varicose vein lasing procedure kit

CyberWand Probe Set - H891CWRBP1

No Description
CYBERSONICS INC
CW-RBP
In Commercial Distribution

  • H891CWRBPBX3 ()
  • H891CWRBP1 ()


  • Ultrasonic lithotripsy system handpiece

Universal Funnel Adapter - H862UFALL0

Universal Funnel Adapter-Luer Lock
URESIL, LLC
UFA-LL
In Commercial Distribution

  • H862UFALL2 ()
  • H862UFALL0 ()
UFA-LL

  • Luer/non-ISO80369-standardized linear connector, single-use

Nephro-Cath Nephrostomy Drainage Catheter - H862NCL21035HBKSA0

Nephrostomy "HB" Catheter + Fixation Kit - Locking - 10F 35
URESIL, LLC
NCL2-1035HB-KSA
Not in Commercial Distribution

  • H862NCL21035HBKSA2 ()
  • H862NCL21035HBKSA0 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NCL2-1035HB-KSA

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - H862NCL21035HBKS1

NEPHRO-CATH Nephrostomy Drainage Catheter Kit - 10F
URESIL, LLC
NCL2-1035HB-K
Not in Commercial Distribution

  • H862NCL21035HBKS2 ()
  • H862NCL21035HBKS1 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NCL2-1035HB-K

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - H862NCL21035HBK0

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER KIT WITH DEPTH MARKS, 10F
URESIL, LLC
NCL2-1035HB-K
In Commercial Distribution

  • H862NCL21035HBK2 ()
  • H862NCL21035HBK0 ()

  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
NCL2-1035HB-K

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - H862NCL20835HBKSA0

Nephrostomy "HB" Catheter + Fixation Kit - Locking - 8F 35
URESIL, LLC
NCL2-0835HB-KSA
Not in Commercial Distribution

  • H862NCL20835HBKSA2 ()
  • H862NCL20835HBKSA0 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
NCL2-0835HB-KSA

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - H862NCL20835HBKS1

NEPHRO-CATH Nephrostomy Drainage Catheter Kit - 8F
URESIL, LLC
NCL2-0835HB-K
Not in Commercial Distribution

  • H862NCL20835HBKS2 ()
  • H862NCL20835HBKS1 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
NCL2-0835HB-K

  • Nephrostomy catheter

Nephro-Cath Nephrostomy Drainage Catheter - H862NCL20835HBK0

HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER KIT WITH DEPTH MARKS, 8F
URESIL, LLC
NCL2-0835HB-K
In Commercial Distribution

  • H862NCL20835HBK2 ()
  • H862NCL20835HBK0 ()

  • Catheter Gauge: 8 French
  • Length: 28 Centimeter
NCL2-0835HB-K

  • Nephrostomy catheter

GP General Purpose Drainage Catheter - H862GPL21030HBKSA0

G-P "HB" Catheter + Fixation Kit - Locking - 10F 30
URESIL, LLC
GPL2-1030HB-KSA
Not in Commercial Distribution

  • H862GPL21030HBKSA2 ()
  • H862GPL21030HBKSA0 ()

  • Catheter Gauge: 10 French
  • Length: 21 Centimeter
GPL2-1030HB-KSA

  • Suction system catheter, general-purpose

GP General Purpose Drainage Catheter - H862GPL20830HBKSA0

G-P "HB" Catheter + Fixation Kit - Locking - 8F 30
URESIL, LLC
GPL2-0830HB-KSA
Not in Commercial Distribution

  • H862GPL20830HBKSA2 ()
  • H862GPL20830HBKSA0 ()

  • Catheter Gauge: 8 French
  • Length: 21 Centimeter
GPL2-0830HB-KSA

  • Suction system catheter, general-purpose

Dale Nasogastric Tube Holder - H84101601

Dale Nasogastric Tube Holder, Large/Adult
Dale Medical Products, Inc.
160
In Commercial Distribution

  • H84101602 ()
  • H84101601 ()
160

  • Nasogastric tube holder, noninvasive

V-Cide - H816VC3380

Formaldehyde Device Sterilant
CERTOL INTERNATIONAL, LLC
VC338
In Commercial Distribution

  • H816VC3381 ()
  • H816VC3380 ()
VC338-1

  • Formaldehyde device sterilant

ProChek S - H816TSI4401

Steam Sterilization Integrators
CERTOL INTERNATIONAL, LLC
TSI440
In Commercial Distribution

  • H816TSI4401 ()
  • H816TSI4400 ()
  • H816TSI4402 ()
TSI440-1

  • Chemical/physical sterilization process indicator

Spec Clean Endoscope Sponge - H816SMQEZ21

Enzymatic Presaturated Endoscopic Cleaning Sponge
MicroCare, LLC
SMQEZ2
In Commercial Distribution

  • H816SMQEZ22 ()
  • H816SMQEZ21 ()
  • H816QEZ21 ()
QEZ2

  • Medical device cleaning agent

ProChek ID - H816SM43401

Indicator Strips for Steam and Chemical Vapor
CERTOL INTERNATIONAL, LLC
SM4340
In Commercial Distribution

  • H816SM43402 ()
  • H816SM43401 ()
  • H816SM43400 ()
SM4340-1

  • Chemical/physical sterilization process indicator

QEZ - H816QEZ21

No Description
CERTOL INTERNATIONAL, LLC
QEZ2
In Commercial Distribution

  • H816QEZ22 ()
  • H816QEZ21 ()
  • H816QEZ20 ()
QEZ2

  • Medical device cleaning agent

ProView plus - H816PM24401

Self Sealing Sterilization Pouch/Packaging 2 1/4" x 4"
CERTOL INTERNATIONAL, LLC
PM2440
In Commercial Distribution

  • H816PM24402 ()
  • H816PM24401 ()
  • H816PM24400 ()
PM2440-1

  • Sterilization packaging, single-use

ProTector - H816MPNS1001

Needle Sheath Prop
MicroCare, LLC
PNS100
In Commercial Distribution

  • H816MPNS1002 ()
  • H816MPNS1001 ()
  • H816MPNS1000 ()
  • H816PNS1001 ()
PNS100-1

  • Surgical instrument interim-placement holder, single-use

ProBarrier - H816MBB0312H1

Environmental Surface Barrier, 3 x 12 instrument/equipment drape, chair sox
MicroCare, LLC
BB-0312H
In Commercial Distribution

  • H816MBB0312H2 ()
  • H816MBB0312H1 ()
  • H816MBB0312H0 ()
  • H816BB0312H1 ()
BB-0312H-1

  • Medical equipment drape, single-use

Barrier - H816BB2930C1

29 x 30 Instrument / equipment drape chair sox
CERTOL INTERNATIONAL, LLC
BB-2930C
In Commercial Distribution

  • H816BB2930C2 ()
  • H816BB2930C1 ()
  • H816BB2930C0 ()
BB-2930C-1

  • Instrument/equipment drape, single-use, non-sterile

VenaCure EVLT - H787EVLTPVAK0

VenaCure 400 Micron Fiber Procedure Kit
ANGIODYNAMICS, INC.
EVLT/PVAK
In Commercial Distribution

  • H787EVLTPVAK0 ()
  • H787EVLTPVAK5 ()

  • Outer Diameter: 1.5 Millimeter
  • Needle Gauge: 21 Gauge


  • Varicose vein lasing procedure kit

VenaCure EVLT - H787EVLT55OPS0

VenaCure 55cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector
ANGIODYNAMICS, INC.
EVLT/55-OPS
In Commercial Distribution

  • H787EVLT55OPS0 ()
  • H787EVLT55OPS5 ()

  • Needle Gauge: 19 Gauge
  • Outer Diameter: 1.2 Millimeter
  • Length: 55 Centimeter
  • Catheter Gauge: 4 French


  • Varicose vein lasing procedure kit

ADx - H7879115351500

GUIDEWIRE, PTFE 035 X 150CM MC 3MM J Amplatz
ANGIODYNAMICS, INC.
911535150
In Commercial Distribution

  • 15051684019804 ()
  • H7879115351500 ()
  • H7879115351501 ()

  • Outer Diameter: 0.035 Inch
  • Length: 150 Centimeter
  • .035" x 150cm x 3mm J


  • Peripheral vascular guidewire, manual

ADx - H7879106381500

GUIDEWIRE, PTFE 038 X 150CM MC 1.5MM J
ANGIODYNAMICS, INC.
910638150
Not in Commercial Distribution

  • 15051684019798 ()
  • H7879106381500 ()
  • H7879106381501 ()

  • Outer Diameter: 0.038 Inch
  • Length: 150 Centimeter
  • .038" x 150cm x 1.5mm J


  • Peripheral vascular guidewire, manual

ADx - H7879105381800

GUIDEWIRE, PTFE 038 X 180CM MC 3MM J
ANGIODYNAMICS, INC.
910538180
In Commercial Distribution

  • 15051684019774 ()
  • H7879105381800 ()
  • H7879105381801 ()

  • Length: 180 Centimeter
  • Outer Diameter: 0.038 Inch
  • .038" x 180cm x 3mm J


  • Peripheral vascular guidewire, manual

ADx - H7879105351500

GUIDEWIRE, PTFE 035 X 150CM MC 3MM J
ANGIODYNAMICS, INC.
910535150
In Commercial Distribution

  • 15051684019750 ()
  • H7879105351500 ()
  • H7879105351501 ()

  • .035" x 150cm x 3MM J
  • Outer Diameter: 0.035 Inch
  • Length: 150 Centimeter


  • Peripheral vascular guidewire, manual

ADx - H7878166381800

GUIDEWIRE, PTFE 038 X 180CM FC 1.5MM J ROSEN
ANGIODYNAMICS, INC.
816638180
In Commercial Distribution

  • 15051684019729 ()
  • H7878166381800 ()
  • H7878166381801 ()

  • Length: 180 Centimeter
  • .038" x 180cm x 1.5mm J
  • Outer Diameter: 0.038 Inch


  • Peripheral vascular guidewire, manual

ADx - H7878166350800

GUIDEWIRE, PTFE 035 X 080CM FC 1.5MM J ROSEN
ANGIODYNAMICS, INC.
816635080
In Commercial Distribution

  • 15051684019675 ()
  • H7878166350800 ()
  • H7878166350801 ()

  • .035" x 80cm x 1.5mm J
  • Outer Diameter: 0.035 Inch
  • Length: 80 Centimeter


  • Peripheral vascular guidewire, manual

ADx - H7878154381500

GUIDEWIRE, PTFE 038 X 150CM FC ST NEWTON LLLT
ANGIODYNAMICS, INC.
815438150
In Commercial Distribution

  • 15051684019644 ()
  • H7878154381500 ()
  • H7878154381501 ()

  • Length: 150 Centimeter
  • .038" x 150cm
  • Outer Diameter: 0.038 Inch


  • Peripheral vascular guidewire, manual

ADx - H7878153381500

GUIDEWIRE, PTFE 038 X 150CM FC ST NEWTON LLT
ANGIODYNAMICS, INC.
815338150
In Commercial Distribution

  • 15051684019620 ()
  • H7878153381500 ()
  • H7878153381501 ()

  • Outer Diameter: 0.038 Inch
  • .038" x 150cm
  • Length: 150 Centimeter


  • Peripheral vascular guidewire, manual

ADx - H7878153320600

GUIDEWIRE, PTFE 032 X 60CM FC ST NEWTON LLT
ANGIODYNAMICS, INC.
815332060
In Commercial Distribution

  • 15051684019606 ()
  • H7878153320600 ()
  • H7878153320601 ()

  • .032" x 60cm
  • Length: 60 Centimeter
  • Outer Diameter: 0.032 Inch


  • Peripheral vascular guidewire, manual

ADx - H7878153180600

GUIDEWIRE, PTFE 018 X 60CM FC ST NEWTON LLT
ANGIODYNAMICS, INC.
815318060
In Commercial Distribution

  • 15051684019583 ()
  • H7878153180600 ()
  • H7878153180601 ()

  • Length: 60 Centimeter
  • .018" x 60cm
  • Outer Diameter: 0.018 Inch


  • Peripheral vascular guidewire, manual

ADx - H7878141382600

GUIDEWIRE, PTFE 038 X 260CM FC ST BENTSON
ANGIODYNAMICS, INC.
814138260
In Commercial Distribution

  • 15051684019552 ()
  • H7878141382600 ()
  • H7878141382601 ()

  • Length: 260 Centimeter
  • .038" x 260cm
  • Outer Diameter: 0.038 Inch


  • Peripheral vascular guidewire, manual

ADx - H7878141380800

GUIDEWIRE, PTFE 038 X 080CM FC ST BENTSON
ANGIODYNAMICS, INC.
814138080
In Commercial Distribution

  • 15051684019538 ()
  • H7878141380800 ()
  • H7878141380801 ()

  • .038" x 80cm
  • Outer Diameter: 0.038 Inch
  • Length: 80 Centimeter


  • Peripheral vascular guidewire, manual

ADx - H7878141351800

GUIDEWIRE, PTFE 035 X 180CM FC ST BENTSON
ANGIODYNAMICS, INC.
H7878141351800
In Commercial Distribution

  • 15051684019514 ()
  • H7878141351800 ()
  • H7878141351801 ()

  • Length: 180 Centimeter
  • Outer Diameter: 0.035 Inch
  • .035" x 180cm


  • Peripheral vascular guidewire, manual

ADx - H7878141350800

GUIDEWIRE, PTFE 035 X 80CM FC ST BENTSON
ANGIODYNAMICS, INC.
814135080
In Commercial Distribution

  • 15051684019491 ()
  • H7878141350800 ()
  • H7878141350801 ()

  • Outer Diameter: 0.035 Inch
  • .035" x 80cm
  • Length: 80 Centimeter


  • Peripheral vascular guidewire, manual

ADx - H7878109351500

GUIDEWIRE, PTFE 035 X 150CM FC 3MM J DE
ANGIODYNAMICS, INC.
810935150
In Commercial Distribution

  • 15051684019224 ()
  • H7878109351500 ()
  • H7878109351501 ()

  • Outer Diameter: 0.035 Inch
  • .035" x 150cm x 3mm J
  • Length: 150 Centimeter


  • Peripheral vascular guidewire, manual
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