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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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GalaFLEX - 00855920006645

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-48
In Commercial Distribution

  • 00855920006645 ()

  • Height: 18.0 Centimeter
  • Length: 10.1 Centimeter
CE019M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006607

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-34
In Commercial Distribution

  • 00855920006607 ()

  • Height: 15.0 Centimeter
  • Length: 20.0 Centimeter
CE0608

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006584

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-35
In Commercial Distribution

  • 00855920006584 ()

  • Height: 5.0 Centimeter
  • Length: 20.0 Centimeter
CE0208

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006560

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-33
In Commercial Distribution

  • 00855920006560 ()

  • Height: 2.5 Centimeter
  • Length: 7.6 Centimeter
CE0103

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006690

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-37
In Commercial Distribution

  • 00855920006690 ()

  • Height: 2.5 Centimeter
  • Length: 10.2 Centimeter
CE0104

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006676

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-46
In Commercial Distribution

  • 00855920006676 ()

  • Height: 22.0 Centimeter
  • Length: 8.6 Centimeter
CE017S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006652

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-40
In Commercial Distribution

  • 00855920006652 ()

  • Height: 22.0 Centimeter
  • Length: 9.0 Centimeter
CE013S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006638

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-49
In Commercial Distribution

  • 00855920006638 ()

  • Height: 14.0 Centimeter
  • Length: 7.8 Centimeter
CE019S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006621

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-42
In Commercial Distribution

  • 00855920006621 ()

  • Height: 26.0 Centimeter
  • Length: 11.9 Centimeter
CE016M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006614

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-43
In Commercial Distribution

  • 00855920006614 ()

  • Height: 22.0 Centimeter
  • Length: 10.0 Centimeter
CE016S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006591

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-36
In Commercial Distribution

  • 00855920006591 ()

  • Height: 10.0 Centimeter
  • Length: 20.0 Centimeter
CE0408

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX - 00855920006577

GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100035-30
In Commercial Distribution

  • 00855920006577 ()

  • Height: 5.0 Centimeter
  • Length: 15.0 Centimeter
CE0206

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Epredia - 00673693170383

Mounting Medium is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage.
RICHARD-ALLAN SCIENTIFIC COMPANY
Mounting Medium
In Commercial Distribution

  • 00673693170383 ()
4112

  • Microscopy mounting medium IVD

Epredia - 00673693073189

Mounting Medium is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage.
RICHARD-ALLAN SCIENTIFIC COMPANY
Mounting Medium
In Commercial Distribution

  • 00673693073189 ()
4111

  • Microscopy mounting medium IVD

Persona Medical - 00851362008315

This is a deep fitting In-The-canal (ITC) custom hearing aid. The device is used for mild to severe hearing loss; this is programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Persona Medical
Ole Deep CIC Custom Hearing Aid
Not in Commercial Distribution

  • 00851362008315 ()


  • Air-conduction hearing aid, in-the-ear

206 Electrometer - 00862246000301

The CNMC Model 206 is a medical dosimeter or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected.
CNMC CO., INC.
206
In Commercial Distribution

206

  • Radiation electrometer

Anti-H (Ulex europaeus) - 10888234000723

Anti-H (Ulex europaeus) is used in the detection of H (H1) antigen on red blood cells and in saliva by tube test. This is a lectin product. This product is in a single vial configuration.
IMMUCOR, INC.
0007151
In Commercial Distribution

  • 10888234000723 ()
0007151

  • Anti-H red blood cell grouping IVD, lectin

CROSPERIO RX - 04540778163515

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B40200LR
In Commercial Distribution

  • 04540778163515 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 1500 mm
  • Balloon Length; 200 mm
  • Balloon Diameter; 4.0 mm
BD-B40200LR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162815

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B35150MR
In Commercial Distribution

  • 04540778162815 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 3.5 mm
BD-B35150MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162792

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B30150MR
In Commercial Distribution

  • 04540778162792 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 3.0 mm
BD-B30150MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162778

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B25150MR
In Commercial Distribution

  • 04540778162778 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 2.5 mm
BD-B25150MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162754

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B20150MR
In Commercial Distribution

  • 04540778162754 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 150 mm
  • Balloon Diameter; 2.0 mm
BD-B20150MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162730

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B40120MR
In Commercial Distribution

  • 04540778162730 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 4.0 mm
BD-B40120MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162716

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B35120MR
In Commercial Distribution

  • 04540778162716 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 3.5 mm
BD-B35120MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162693

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B30120MR
In Commercial Distribution

  • 04540778162693 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 3.0 mm
BD-B30120MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162679

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B25120MR
In Commercial Distribution

  • 04540778162679 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 2.5 mm
BD-B25120MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162655

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B20120MR
In Commercial Distribution

  • 04540778162655 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 2.0 mm
BD-B20120MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162631

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B15120MR
In Commercial Distribution

  • 04540778162631 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 120 mm
  • Balloon Diameter; 1.5 mm
BD-B15120MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162617

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B40080MR
In Commercial Distribution

  • 04540778162617 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 4.0 mm
BD-B40080MR

  • Peripheral angioplasty balloon catheter, basic

CROSPERIO RX - 04540778162594

CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
BD-B35080MR
In Commercial Distribution

  • 04540778162594 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Sheath Diameter; 4 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 8 atm
  • Proximal Shaft Diameter; 3.5 Fr
  • Distal Shaft Diameter; 3.5 Fr
  • Catheter Working Length; 900 mm
  • Balloon Length; 80 mm
  • Balloon Diameter; 3.5 mm
BD-B35080MR

  • Peripheral angioplasty balloon catheter, basic
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