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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FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII018AS
In Commercial Distribution

  • 00690103168358 ()

  • 18 Fr. (6.0 mm) x 15 cm (6")
FEMII018AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII016AS
In Commercial Distribution

  • 00690103168341 ()

  • 16 Fr. (5.3 mm) x 15 cm (6")
FEMII016AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM028
In Commercial Distribution

  • 00690103146684 ()

  • 28 Fr. (9.3 mm) x 68 cm (26.8")
VFEM028

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM024
In Commercial Distribution

  • 00690103146677 ()

  • 24 Fr. (8.0 mm) x 68 cm (26.8")
VFEM024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM022
In Commercial Distribution

  • 00690103146660 ()

  • 22 Fr. (7.3 mm) x 55 cm (21.6")
VFEM022

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM020
In Commercial Distribution

  • 00690103146653 ()

  • 20 Fr. (6.7 mm) x 55 cm (21.6")
VFEM020

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM018
In Commercial Distribution

  • 00690103146646 ()

  • 18 Fr. (6.0 mm) x 55 cm (21.6")
VFEM018

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
15 Fr x 17 cm femoral arterial cannula with 10 Fr introducer
CARDIACASSIST, INC.
5130-1715
In Commercial Distribution

  • 00814112020111 ()
5130-1715

  • Cardiopulmonary bypass cannula, femoral
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .25mm Burlite Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
UBKILTBLOCKERSET
In Commercial Distribution

  • 00840331252033 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm Burlite Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
SBKILTBLOCKERSET
In Commercial Distribution

  • 00840331251975 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm Burlite Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
RBKILTBLOCKERSET
In Commercial Distribution

  • 00840331251913 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .25mm Envirolite Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
UEKILTBLOCKERSET
In Commercial Distribution

  • 00840331244229 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm Envirolite Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
SEKILTBLOCKERSET
In Commercial Distribution

  • 00840331244168 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm Envirolite Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
REKILTBLOCKERSET
In Commercial Distribution

  • 00840331244106 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .35mm Lead Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
SLKILTBLOCKERSET
In Commercial Distribution

  • 00840331258097 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .5mm Lead Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
RLKILTBLOCKERSET
In Commercial Distribution

  • 00840331258035 ()


  • Radiation shielding apron
KILT BLOCKER SET - Standard Size with Hook and Loop Closure, .25mm Lead Size SET, 18"L X 20"W, 20"L X 24"W, 24"L X 24"W
BURLINGTON MEDICAL, LLC
ULKILTBLOCKERSET
In Commercial Distribution

  • 00840331258158 ()


  • Radiation shielding apron
NEXIVA 24 GA X 0.75IN SP WITH MAXZERO
BECTON, DICKINSON AND COMPANY
383551
In Commercial Distribution

  • 50382903835510 ()
  • 00382903835515 ()
  • 30382903835516 ()
383551

  • Peripheral intravenous cannula
NEXIVA 24 GA X 0.56IN SP WITH MAXZERO
BECTON, DICKINSON AND COMPANY
383550
In Commercial Distribution

  • 50382903835503 ()
  • 00382903835508 ()
  • 30382903835509 ()
383550

  • Peripheral intravenous cannula
Small Hyperlordotic 3DP ALIF 20mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D2024S0 ()

  • Height: 20 Millimeter
  • Angle: 24 degree
GHA3D-2024S

  • Metallic spinal fusion cage, non-sterile
Medium Hyperlordotic 3DP ALIF 20mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D2024M0 ()

  • Height: 20 Millimeter
  • Angle: 24 degree
GHA3D-2024M

  • Metallic spinal fusion cage, non-sterile
Large Hyperlordotic 3DP ALIF 20mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D2024L0 ()

  • Height: 20 Millimeter
  • Angle: 24 degree
GHA3D-2024L

  • Metallic spinal fusion cage, non-sterile
Ovoid Hyperlordotic 3DP ALIF 20mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D2024K0 ()

  • Length: 20 Millimeter
  • Angle: 24 degree
GHA3D-2024K

  • Metallic spinal interbody fusion cage
Small Hyperlordotic 3DP ALIF 18mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1824S0 ()

  • Height: 18 Millimeter
  • Angle: 24 degree
GHA3D-1824S

  • Metallic spinal fusion cage, non-sterile
Medium Hyperlordotic 3DP ALIF 18mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1824M0 ()

  • Height: 18 Millimeter
  • Angle: 24 degree
GHA3D-1824M

  • Metallic spinal fusion cage, non-sterile
Large Hyperlordotic 3DP ALIF 18mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1824L0 ()

  • Height: 18 Millimeter
  • Angle: 24 degree
GHA3D-1824L

  • Metallic spinal fusion cage, non-sterile
Ovoid Hyperlordotic 3DP ALIF 18mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1824K0 ()

  • Height: 18 Millimeter
  • Angle: 24 degree
GHA3D-1824K

  • Metallic spinal interbody fusion cage
Small Hyperlordotic 3DP ALIF 16mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1624S0 ()

  • Height: 24 Millimeter
  • Angle: 24 degree
GHA3D-1624S

  • Metallic spinal fusion cage, non-sterile
Medium Hyperlordotic 3DP ALIF 16mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1624M0 ()

  • Height: 16 Millimeter
  • Angle: 24 degree
GHA3D-1624M

  • Metallic spinal fusion cage, non-sterile
Small Hyperlordotic 3DP ALIF 14mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1424S0 ()

  • Height: 14 Millimeter
  • Angle: 24 degree
GHA3D-1424S

  • Metallic spinal fusion cage, non-sterile
CUSTOM PACK 0W18R2 10PK 24 M/M LINE
MEDTRONIC, INC.
0W18R2
In Commercial Distribution

  • 20721902844748 ()
  • 00721902844744 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 0W17R3 10PK 24 M/F LINE
MEDTRONIC, INC.
0W17R3
In Commercial Distribution

  • 20721902844717 ()
  • 00721902844713 ()


  • Cardiopulmonary bypass system blood tubing set
BANDAGE,CURAD,VARIETY PACK,30CT,24/BX/CS
MEDLINE INDUSTRIES, INC.
CUR47443RB
In Commercial Distribution

  • 30884389111011 ()
  • 00884389111010 ()
  • 40884389111018 ()
  • 80884389111016 ()
CUR47443RB

  • Adhesive bandage
READI-CUT TEVDEK GREEN BRAIDED SIZE 2 24 INCHES
TELEFLEX INCORPORATED
IPN914877
In Commercial Distribution

  • 34026704673187 ()
  • 14026704673183 ()
  • 24026704673180 ()
122-TR

  • Polyester suture, non-bioabsorbable, multifilament
READI-CUT SILK BLACK BRAIDED SIZE 2 24 INCHES
TELEFLEX INCORPORATED
IPN914876
In Commercial Distribution

  • 34026704673170 ()
  • 14026704673176 ()
  • 24026704673173 ()
122-R

  • Polyester suture, non-bioabsorbable, multifilament
POL GN BR 3-0 KT-2 2N 24" PSP
TELEFLEX INCORPORATED
IPN055543
In Commercial Distribution

  • 24026704738025 ()
  • 14026704738028 ()
  • 14026704426543 ()

  • 'silky' II POLYDEK® /Needle KT-2, KT-2 Size-3-0
  • Length: 60 Centimeter
X-4461

  • Polyester suture, non-bioabsorbable, multifilament
Vesocclude Titanium Medium Non-Sterile 24/cartridge 100 /BOX
TELEFLEX INCORPORATED
IPN926195
In Commercial Distribution

  • 34026704733478 ()
  • 24026704733471 ()
  • 14026704733474 ()
  • 54026704733472 ()
50415NS

  • Ligation clip, metallic
DEKLENE MAXX BLUE MONOFILAMENT 4-0 T-2 2N 24"
TELEFLEX INCORPORATED
IPN927818
In Commercial Distribution

  • 24026704730470 ()
  • 14026704731302 ()
  • 04026704591633 ()

  • Length: 60 Centimeter
  • DEKLENE® MAXX™ /Needle T-2, T-2 Size-4-0
D-737K

  • Polyolefin/fluoropolymer suture, monofilament
DEKLENE MAXX BLUE MONOFILAMENT 6-0 T-10 2N 24"
TELEFLEX INCORPORATED
IPN927817
In Commercial Distribution

  • 24026704730203 ()
  • 14026704730206 ()
  • 04026704591596 ()

  • DEKLENE® MAXX™ /Needle T-10, T-10 Size-6-0
  • Length: 60 Centimeter
D-7275K

  • Polyolefin/fluoropolymer suture, monofilament
DEKLENE MAXX BLUE MONOFILAMENT 6-0 XT-1 2N 24"
TELEFLEX INCORPORATED
IPN927799
In Commercial Distribution

  • 24026704730067 ()
  • 14026704730060 ()
  • 04026704591145 ()

  • Length: 60 Centimeter
  • DEKLENE® MAXX™ /Needle XT-1, XT-1 Size-6-0
D-7016K

  • Polyolefin/fluoropolymer suture, monofilament
CTY GN BR 2 K-61 1N 24"X5
TELEFLEX INCORPORATED
IPN914546
In Commercial Distribution

  • 24026704670530 ()
  • 14026704670533 ()

  • Length: 60 Centimeter
  • cottony'™ II /Needle K-61 Size-2
X-6037M5

  • Polyester suture, non-bioabsorbable, multifilament
24 EA ISI DA VINCI Si 8MM OBTURATOR
TELEFLEX INCORPORATED
IPN028436
In Commercial Distribution

  • 24026704629583 ()
  • 14026704629586 ()
  • 34026704629580 ()
  • 04026704428717 ()
420023

  • Laparoscopic trocar blade, single-use
SLK BK BR 1 CE-1 1N 24" RN
TELEFLEX INCORPORATED
IPN026984
In Commercial Distribution

  • 34026704427421 ()
  • 14026704427427 ()
  • 04026704427420 ()

  • SILK /Needle CE-1 Size-1
  • Length: 60 Centimeter
X-5642

  • Silk suture
Nylon Black Monofilament Size 3-0 24" T-2 Needle
TELEFLEX INCORPORATED
IPN000846
In Commercial Distribution

  • 34026704602415 ()
  • 14026704602411 ()

  • Suture length 24", Needle length .700"
0100019-540

  • Nylon suture, non-bioabsorbable, monofilament
TEV WH BR 5-0 AT-6 2N 24" PFS
TELEFLEX INCORPORATED
IPN009776
In Commercial Distribution

  • 34026704590293 ()
  • 14026704590299 ()
  • 04026704590292 ()

  • Length: 60 Centimeter
  • TEVDEK® II /Needle AT-6, AT-6 Size-5-0
7-6595W

  • Polyester suture, non-bioabsorbable, multifilament
CTY GN BR 2 K-61 1N 24"X5
TELEFLEX INCORPORATED
IPN027011
In Commercial Distribution

  • 34026704427520 ()
  • 14026704427526 ()
  • 04026704427529 ()

  • Length: 60 Centimeter
  • 'cottony'™ II /Needle K-61 Size-2
X-6037M5

  • Polyester suture, non-bioabsorbable, multifilament
TEV GN BR 4-0 T-2 2N 24"X6
TELEFLEX INCORPORATED
IPN026799
In Commercial Distribution

  • 34026704426059 ()
  • 14026704426055 ()
  • 04026704426058 ()

  • TEVDEK® II /Needle T-2, T-2 Size-4-0
  • Length: 60 Centimeter
X-3314M6

  • Polyester suture, non-bioabsorbable, multifilament
DEKLENE MAXX BLUE MONOFILAMENT 7-0 XT-6.5 2N 24
TELEFLEX INCORPORATED
IPN028989
In Commercial Distribution

  • 34026704637301 ()
  • 14026704637307 ()
  • 04026704591787 ()

  • Length: 60 Centimeter
  • DEKLENE® MAXX™ /Needle XT-6.5, XT-6.5 Size-7-0
D-7506K

  • Polyolefin/fluoropolymer suture, monofilament
DEKLENE MAXX BLUE MAXX 8-0 XT-7 2N 24"
TELEFLEX INCORPORATED
IPN028981
In Commercial Distribution

  • 34026704637226 ()
  • 14026704637222 ()
  • 04026704591701 ()

  • DEKLENE® MAXX™ /Needle XT-7, XT-7 Size-8-0
  • Length: 60 Centimeter
D-7504K

  • Polyolefin/fluoropolymer suture, monofilament
DEKLENE MAXX BLUE MONOFILAMENT 4-0 T-2 2N 24"
TELEFLEX INCORPORATED
IPN049584
In Commercial Distribution

  • 34026704637165 ()
  • 14026704637161 ()
  • 04026704591633 ()

  • DEKLENE® MAXX™ /Needle T-2, T-2 Size-4-0
  • Length: 60 Centimeter
D-737K

  • Polyolefin/fluoropolymer suture, monofilament
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