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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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SUPARTZ® sodium hyaluronate - M717715655550

SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-5555-01
Not in Commercial Distribution

  • M717715655554 ()
  • M717715655553 ()
  • M717715655552 ()
  • M717715655550 ()
7156-5555

  • Synovial fluid supplementation medium

SUPARTZ FX sodium hyaluronate - M717715644440

SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-4444-1
In Commercial Distribution

  • M717715644440 ()
  • M717715644442 ()
  • M717715644443 ()
  • M717715644444 ()
7156-4444

  • Synovial fluid supplementation medium

Cardiva VASCADE MVP VVCS 6-12F - M729800612C0

The VASCADE MVP Venous Vascular Closure System (VVCS) 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 6Fr 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.
800-612C
In Commercial Distribution

  • M729800612C2 ()
  • M729800612C0 ()
  • M729800612C1 ()
  • M729800612C3 ()

  • Catheter Gauge: 6 to 12 French


  • Femoral artery closure plug/patch, collagen

Axiom® Lig-A-Loops® - M6651180

Retraction Tape, Mini, Blue, Veins
AXIOM MEDICAL, INCORPORATED
118
In Commercial Distribution

  • M6651185 ()
  • M6651183 ()
  • M6651181 ()
  • M6651180 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651170

Retraction Tape, Mini, White, Nerves
AXIOM MEDICAL, INCORPORATED
117
In Commercial Distribution

  • M6651175 ()
  • M6651173 ()
  • M6651171 ()
  • M6651170 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651160

Retraction Tape, Mini, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
116
In Commercial Distribution

  • M6651165 ()
  • M6651163 ()
  • M6651161 ()
  • M6651160 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651150

Retraction Tape, Mini, Red, Arteries
AXIOM MEDICAL, INCORPORATED
115
In Commercial Distribution

  • M6651155 ()
  • M6651153 ()
  • M6651151 ()
  • M6651150 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651140

Retraction Tape, Maxi, Blue, Veins
AXIOM MEDICAL, INCORPORATED
114
In Commercial Distribution

  • M6651145 ()
  • M6651143 ()
  • M6651141 ()
  • M6651140 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651130

Retraction Tape, Maxi, White, Nerves
AXIOM MEDICAL, INCORPORATED
113
In Commercial Distribution

  • M6651135 ()
  • M6651133 ()
  • M6651131 ()
  • M6651130 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651120

Retraction Tape, Maxi, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
112
In Commercial Distribution

  • M6651125 ()
  • M6651123 ()
  • M6651121 ()
  • M6651120 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651110

Retraction Tape, Maxi, Red, Arteries
AXIOM MEDICAL, INCORPORATED
111
In Commercial Distribution

  • M6651115 ()
  • M6651113 ()
  • M6651111 ()
  • M6651110 ()


  • Surgical support tape, non-bioabsorbable

Ch24 round silicone catheter - M640R99000990011

No Description
RAND SPA
001
In Commercial Distribution

  • M640R99000990012 ()
  • M640R99000990011 ()
  • M640R99000990013 ()
  • M640R99000990014 ()

  • Length: 600 Millimeter
  • Catheter Gauge: 24 French
R9900099

  • Multi-purpose percutaneous abdominothoracic drainage catheter

Ch24 round silicone catheter - M640R99000990001

No Description
RAND SPA
000
Not in Commercial Distribution

  • M640R99000990001 ()
  • M640R99000990002 ()
  • M640R99000990003 ()
  • M640R99000990004 ()

  • Length: 600 Millimeter
  • Catheter Gauge: 24 French
R9900099

  • Multi-purpose percutaneous abdominothoracic drainage catheter

InoMesh - MDLXMAG115200

MAG1-1520: 15cm x 20cm (6in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1520
In Commercial Distribution

  • MDLXMAG115200 ()
  • MDLXMAG115203 ()
  • MDLXMAG115202 ()
  • MDLXMAG115201 ()
MAG1-1520

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG120300

MAG1-2030: 20cm x 30cm (8in x 12in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2030
In Commercial Distribution

  • MDLXMAG120300 ()
  • MDLXMAG120303 ()
  • MDLXMAG120302 ()
  • MDLXMAG120301 ()
MAG1-2030

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG120200

MAG1-2020: 20cm x 20cm (8in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2020
In Commercial Distribution

  • MDLXMAG120200 ()
  • MDLXMAG120203 ()
  • MDLXMAG120202 ()
  • MDLXMAG120201 ()
MAG1-2020

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115150

MAG1-1515: 15cm x 15cm (6in x 6in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1515
In Commercial Distribution

  • MDLXMAG115150 ()
  • MDLXMAG115153 ()
  • MDLXMAG115152 ()
  • MDLXMAG115151 ()
MAG1-1515

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115100

MAG1-1510: 15cm x 10cm (6in x 4in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1510
In Commercial Distribution

  • MDLXMAG115100 ()
  • MDLXMAG115103 ()
  • MDLXMAG115102 ()
  • MDLXMAG115101 ()
MAG1-1510

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

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

ProVeil Hydrogel Membrane - B130PV40300

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

Checkpoint NeuroShield Chitosan Membrane - B130NS30200

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

Checkpoint NeuroShield Chitosan Membrane - B130NS40300

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

Cardiva VASCADE 6/7F VCS - M729700580I0

The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution

  • M729700580I1 ()
  • M729700580I0 ()
  • M729700580I3 ()

  • Catheter Gauge: 7 French
  • Catheter Gauge: 6 French


  • Femoral artery closure plug/patch, collagen

Cardiva VASCADE 5F VCS - M729700500DX0

The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution

  • M729700500DX1 ()
  • M729700500DX0 ()
  • M729700500DX3 ()

  • Catheter Gauge: 5 French


  • Femoral artery closure plug/patch, collagen

DuraMax - H787103028180

15.5F x 24cm Chronic Hemodialysis VascPak Kit (with Cuff 19cm from Tip)
ANGIODYNAMICS, INC.
10302818
In Commercial Distribution

  • H787103028185 ()
  • H787103028180 ()
  • H787103028181 ()
  • 15051684011921 ()

  • Catheter Gauge: 15.5 French
  • Length: 24 Centimeter


  • Double-lumen haemodialysis catheter, implantable

DuraMax - H787103028060

15.5F x 36cm Chronic Hemodialysis Catheter Set (with Cuff 31cm from Tip)
ANGIODYNAMICS, INC.
10302806
In Commercial Distribution

  • H787103028061 ()
  • H787103028060 ()
  • H787103028065 ()
  • 15051684011860 ()

  • Catheter Gauge: 15.5 French
  • Needle Gauge: 18 Gauge
  • Length: 36 Centimeter


  • Double-lumen haemodialysis catheter, implantable

DuraMax - H787103028050

15.5F x 32cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip)
ANGIODYNAMICS, INC.
10302805
In Commercial Distribution

  • H787103028055 ()
  • H787103028050 ()
  • H787103028051 ()
  • 15051684011853 ()

  • Catheter Gauge: 15.5 French
  • Needle Gauge: 18 Gauge
  • Length: 32 Centimeter


  • Double-lumen haemodialysis catheter, implantable

DuraMax - H787103028040

15.5F x 28cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip)
ANGIODYNAMICS, INC.
10302804
In Commercial Distribution

  • H787103028041 ()
  • H787103028040 ()
  • H787103028045 ()
  • 15051684011846 ()

  • Catheter Gauge: 15.5 French
  • Length: 28 Centimeter
  • Needle Gauge: 18 Gauge


  • Double-lumen haemodialysis catheter, implantable

DuraMax - H787103028030

15.5F x 24cm Chronic Hemodialysis Catheter Set (with Cuff 19cm from Tip)
ANGIODYNAMICS, INC.
10302803
In Commercial Distribution

  • H787103028031 ()
  • H787103028030 ()
  • H787103028035 ()
  • 15051684011839 ()

  • Length: 24 Centimeter
  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 15.5 French


  • Double-lumen haemodialysis catheter, implantable

DuraFlow - H787103012040

DuraFlow 2 - 15.5F x 36cm Chronic Hemodialysis Catheter Set (with Cuff 31cm from Tip)
ANGIODYNAMICS, INC.
10301204
In Commercial Distribution

  • H787103012045 ()
  • H787103012040 ()
  • H787103012041 ()
  • 15051684014762 ()

  • Needle Gauge: 18 Gauge
  • Catheter Gauge: 15.5 French
  • Length: 36 Centimeter


  • Double-lumen haemodialysis catheter, implantable
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