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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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Lineum® OCT - 00880304982864

No Description
BIOMET SPINE LLC
14-525228E
In Commercial Distribution

  • 00880304982864 ()

  • 6.5 x 28 mm Cross-Connector Head to Head Cross-Connector
14-525228E

  • Bone-screw internal spinal fixation system, sterile

Lineum® OCT - 00880304982857

No Description
BIOMET SPINE LLC
14-525223E
In Commercial Distribution

  • 00880304982857 ()

  • 6.5 x 23 mm Cross-Connector Head to Head Cross-Connector
14-525223E

  • Bone-screw internal spinal fixation system, sterile

Lineum® OCT - 00880304982840

No Description
BIOMET SPINE LLC
14-525156E
In Commercial Distribution

  • 00880304982840 ()

  • 6.0 x 56 mm Cross-Connector Head to Head Cross-Connector
14-525156E

  • Bone-screw internal spinal fixation system, sterile

Lineum® OCT - 00880304982833

No Description
BIOMET SPINE LLC
14-525149E
In Commercial Distribution

  • 00880304982833 ()

  • 6.0 x 49 mm Cross-Connector Head to Head Cross-Connector
14-525149E

  • Bone-screw internal spinal fixation system, sterile

Lineum® OCT - 00880304982826

No Description
BIOMET SPINE LLC
14-525142E
In Commercial Distribution

  • 00880304982826 ()

  • 6.0 x 42 mm Cross-Connector Head to Head Cross-Connector
14-525142E

  • Bone-screw internal spinal fixation system, sterile

Lineum® OCT - 00880304982819

No Description
BIOMET SPINE LLC
14-525135E
In Commercial Distribution

  • 00880304982819 ()

  • 6.0 x 35 mm Cross-Connector Head to Head Cross-Connector
14-525135E

  • Bone-screw internal spinal fixation system, sterile

Lineum® OCT - 00880304982789

No Description
BIOMET SPINE LLC
14-525128E
In Commercial Distribution

  • 00880304982789 ()

  • 4.5 x 28 mm Cross-Connector Head to Head Cross-Connector
14-525128E

  • Bone-screw internal spinal fixation system, sterile

Lineum® OCT - 00880304982772

No Description
BIOMET SPINE LLC
14-525125E
In Commercial Distribution

  • 00880304982772 ()

  • 4.5 x 25 mm Cross-Connector Head to Head Cross-Connector
14-525125E

  • Bone-screw internal spinal fixation system, sterile

GLIDESHEATH SLENDER - 04987350725608

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*CS7F10NA
Not in Commercial Distribution

  • 54987350725603 ()
  • 34987350725609 ()
  • 04987350725608 ()

  • Lumen/Inner Diameter: 2.45 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
RM*CS7F10NA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723222

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS7F16PA
Not in Commercial Distribution

  • 54987350723227 ()
  • 34987350723223 ()
  • 04987350723222 ()

  • Those Clinically Relevant Size are relative to the sheath.
  • Lumen/Inner Diameter: 2.45 Millimeter
  • Length: 16 Centimeter
RM*RS7F16PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723208

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS7F10PA
Not in Commercial Distribution

  • 34987350723209 ()
  • 04987350723208 ()
  • 54987350723203 ()

  • Lumen/Inner Diameter: 2.45 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
RM*RS7F10PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723185

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS7J16PA
Not in Commercial Distribution

  • 54987350723180 ()
  • 34987350723186 ()
  • 04987350723185 ()

  • Length: 16 Centimeter
  • Lumen/Inner Diameter: 2.45 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
RM*RS7J16PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723161

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS7J10PA
Not in Commercial Distribution

  • 34987350723162 ()
  • 04987350723161 ()
  • 54987350723166 ()

  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 2.45 Millimeter
RM*RS7J10PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723109

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES7F16HAU
Not in Commercial Distribution

  • 54987350723104 ()
  • 34987350723100 ()
  • 04987350723109 ()

  • Length: 16 Centimeter
  • Lumen/Inner Diameter: 2.45 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
RM*ES7F16HAU

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723086

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES7F10HAU
Not in Commercial Distribution

  • 54987350723081 ()
  • 34987350723087 ()
  • 04987350723086 ()

  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 2.45 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
RM*ES7F10HAU

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723062

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES7J16HAT
Not in Commercial Distribution

  • 54987350723067 ()
  • 34987350723063 ()
  • 04987350723062 ()

  • Lumen/Inner Diameter: 2.45 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 16 Centimeter
RM*ES7J16HAT

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723048

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES7J10HAT
Not in Commercial Distribution

  • 34987350723049 ()
  • 04987350723048 ()
  • 54987350723043 ()

  • Lumen/Inner Diameter: 2.45 Millimeter
  • Length: 10 Centimeter
  • Those Clinically Relevant Size are relative to the sheath.
RM*ES7J10HAT

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350722782

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS5F16PA
Not in Commercial Distribution

  • 54987350722787 ()
  • 34987350722783 ()
  • 04987350722782 ()

  • Length: 16 Centimeter
  • Lumen/Inner Diameter: 1.78 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
RM*RS5F16PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350722768

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS5F10PA
Not in Commercial Distribution

  • 34987350722769 ()
  • 04987350722768 ()
  • 54987350722763 ()

  • Length: 10 Centimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Lumen/Inner Diameter: 1.78 Millimeter
RM*RS5F10PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350722744

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS5J16PA
Not in Commercial Distribution

  • 54987350722749 ()
  • 34987350722745 ()
  • 04987350722744 ()

  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 16 Centimeter
  • Lumen/Inner Diameter: 1.78 Millimeter
RM*RS5J16PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350722720

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS5J10PA
Not in Commercial Distribution

  • 54987350722725 ()
  • 34987350722721 ()
  • 04987350722720 ()

  • Length: 10 Centimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Lumen/Inner Diameter: 1.78 Millimeter
RM*RS5J10PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350722669

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES5F16HAU
Not in Commercial Distribution

  • 34987350722660 ()
  • 04987350722669 ()
  • 54987350722664 ()

  • Length: 16 Centimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Lumen/Inner Diameter: 1.78 Millimeter
RM*ES5F16HAU

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350722645

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES5F10HAU
Not in Commercial Distribution

  • 34987350722646 ()
  • 04987350722645 ()
  • 54987350722640 ()

  • Lumen/Inner Diameter: 1.78 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
RM*ES5F10HAU

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350722621

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES5J16HAT
Not in Commercial Distribution

  • 34987350722622 ()
  • 04987350722621 ()
  • 54987350722626 ()

  • Length: 16 Centimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Lumen/Inner Diameter: 1.78 Millimeter
RM*ES5J16HAT

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350722607

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES5J10HAT
Not in Commercial Distribution

  • 54987350722602 ()
  • 34987350722608 ()
  • 04987350722607 ()

  • Lumen/Inner Diameter: 1.78 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
RM*ES5J10HAT

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350718082

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS6F16PA
Not in Commercial Distribution

  • 34987350718083 ()
  • 04987350718082 ()
  • 54987350718087 ()

  • Those Clinically Relevant Size are relative to the sheath.
  • Lumen/Inner Diameter: 2.10 Millimeter
  • Length: 16 Centimeter
RM*RS6F16PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350718020

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS6J10PA
Not in Commercial Distribution

  • 54987350718025 ()
  • 34987350718021 ()
  • 04987350718020 ()

  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 2.10 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
RM*RS6J10PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350718006

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES6F16HAU
Not in Commercial Distribution

  • 54987350718001 ()
  • 34987350718007 ()
  • 04987350718006 ()

  • Lumen/Inner Diameter: 2.10 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 16 Centimeter
RM*ES6F16HAU

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350717986

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES6F10HAU
Not in Commercial Distribution

  • 34987350717987 ()
  • 04987350717986 ()
  • 54987350717981 ()

  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 2.10 Millimeter
RM*ES6F10HAU

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350717962

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES6J16HAT
Not in Commercial Distribution

  • 34987350717963 ()
  • 04987350717962 ()
  • 54987350717967 ()

  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 16 Centimeter
  • Lumen/Inner Diameter: 2.10 Millimeter
RM*ES6J16HAT

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350717948

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*ES6J10HAT
Not in Commercial Distribution

  • 34987350717949 ()
  • 04987350717948 ()
  • 54987350717943 ()

  • Lumen/Inner Diameter: 2.10 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
RM*ES6J10HAT

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350725585

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*CS5F10NA
Not in Commercial Distribution

  • 34987350725586 ()
  • 04987350725585 ()
  • 54987350725580 ()

  • Lumen/Inner Diameter: 1.78 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
RM*CS5F10NA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350723246

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*CS6F10NA
Not in Commercial Distribution

  • 34987350723247 ()
  • 04987350723246 ()
  • 54987350723241 ()

  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 2.10 Millimeter
  • Those Clinically Relevant Size are relative to the sheath.
RM*CS6F10NA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350718068

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS6F10PA
Not in Commercial Distribution

  • 34987350718069 ()
  • 04987350718068 ()
  • 54987350718063 ()

  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 10 Centimeter
  • Lumen/Inner Diameter: 2.10 Millimeter
RM*RS6F10PA

  • Vascular catheter introduction set, nonimplantable

GLIDESHEATH SLENDER - 04987350718044

GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
TERUMO CORPORATION
RM*RS6J16PA
Not in Commercial Distribution

  • 54987350718049 ()
  • 34987350718045 ()
  • 04987350718044 ()

  • Those Clinically Relevant Size are relative to the sheath.
  • Length: 16 Centimeter
  • Lumen/Inner Diameter: 2.10 Millimeter
RM*RS6J16PA

  • Vascular catheter introduction set, nonimplantable

Gelfilm - 00300090283018

Anti-adhesion dressing, bioabsorbable
PHARMACIA & UPJOHN COMPANY LLC
Gelfilm® Sterile Film Sterile film 1's (125 sq cm)
Not in Commercial Distribution

  • 00300090283018 ()

  • Width: 100 Millimeter
  • Length: 125 Millimeter
  • Thickness of film ranges from 0.060 to 0.175 mm


  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated

CryoValve® SG Pulmonary Human Heart Valve - 00877234000454

Pulmonary Valve SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV10
In Commercial Distribution

  • 00877234000454 ()

  • Internal Diameter: Ranges from 6mm to 36mm (allograft specific)
SGPV10

  • Cadaveric open-surgery heart valve bioprosthesis, decellularized

CryoValve® SG Pulmonary Human Heart Valve - 00877234000447

Pulmonary Valve and Conduit SG The CryoValve SG Pulmonary Human Heart Valve is a human heart valve aseptically recovered from donated human tissue.
Artivion, Inc.
SGPV00
In Commercial Distribution

  • 00877234000447 ()

  • Internal Diameter: Ranges from 6mm to 36mm (allograft specific)
SGPV00

  • Cadaveric open-surgery heart valve bioprosthesis, decellularized

miniRUMEL™ - 00850200006582

miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device.
LSI Solutions, Inc.
080130
Not in Commercial Distribution

  • 10850200006589 ()
  • 00850200006582 ()

  • Minimum suture length required to use miniRUMEL™ Device.
  • Length: 30 Inch
080130

  • Suture/ligature tightener, single-use

fibre optic adapter - 04250337118510

Fiber Optic Cable Adapter
Joimax GmbH
CSFHD01COAS
In Commercial Distribution

  • 04250337118510 ()

  • for connection of standard fiber optic cables to C
CSFHD01COAS

  • Endoscope video camera

Ophthalmic Caliper - 00841668105047

STAHL CORNEAL CALIPER
KATENA PRODUCTS, INC.
K3-9300
In Commercial Distribution

  • 00841668105047 ()

  • 0.5MM and 1.0 MM sizes from 10.0 to 13MM
K3-9300

  • Ophthalmic calliper

ENDOSKELETON® TAS Sterile Barrier System - 00191375038948

Plate , X-Large, 18mm to 20mm
TITAN SPINE, LLC
2303-1821-S
Not in Commercial Distribution

  • 00191375038948 ()

  • Height: 18 Millimeter
  • Height: 19 Millimeter
  • Footprint, X-Large
  • Height: 20 Millimeter
  • For Use with Heights, 18mm to 20mm
2303-1821-S

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Sterile Barrier System - 00191375038931

Plate , X-Large, 14mm to 17mm
TITAN SPINE, LLC
2303-1417-S
Not in Commercial Distribution

  • 00191375038931 ()

  • Footprint, X-Large
  • For Use with Heights, 14mm to 17mm
  • Height: 15 Millimeter
  • Height: 14 Millimeter
  • Height: 17 Millimeter
  • Height: 16 Millimeter
2303-1417-S

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Sterile Barrier System - 00191375038924

Plate , X-Large, 12mm to 13mm
TITAN SPINE, LLC
2303-1013-S
Not in Commercial Distribution

  • 00191375038924 ()

  • Footprint, X-Large
  • For Use with Heights, 12mm to 13mm
  • Height: 12 Millimeter
  • Height: 13 Millimeter
2303-1013-S

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Sterile Barrier System - 00191375038917

Plate , Large, 18mm to 20mm
TITAN SPINE, LLC
2302-1821-S
Not in Commercial Distribution

  • 00191375038917 ()

  • Height: 20 Millimeter
  • Height: 19 Millimeter
  • Footprint, Large
  • Height: 18 Millimeter
  • For Use with Heights, 18mm to 20mm
2302-1821-S

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Sterile Barrier System - 00191375038900

Plate , Large, 14mm to 17mm
TITAN SPINE, LLC
2302-1417-S
Not in Commercial Distribution

  • 00191375038900 ()

  • Height: 17 Millimeter
  • Height: 14 Millimeter
  • Height: 15 Millimeter
  • Footprint, Large
  • Height: 16 Millimeter
  • For Use with Heights, 14mm to 17mm
2302-1417-S

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Sterile Barrier System - 00191375038894

Plate , Large, 12mm to 13mm
TITAN SPINE, LLC
2302-1013-S
Not in Commercial Distribution

  • 00191375038894 ()

  • For Use with Heights, 12mm to 13mm
  • Height: 12 Millimeter
  • Height: 13 Millimeter
  • Footprint, Large
2302-1013-S

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Sterile Barrier System - 00191375038887

Plate , Standard, 18mm to 20mm
TITAN SPINE, LLC
2301-1821-S
Not in Commercial Distribution

  • 00191375038887 ()

  • Height: 19 Millimeter
  • For Use with Heights, 18mm to 20mm
  • Footprint, Standard
  • Height: 18 Millimeter
  • Height: 20 Millimeter
2301-1821-S

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Sterile Barrier System - 00191375038870

Plate , Standard, 14mm to 17mm
TITAN SPINE, LLC
2301-1417-S
Not in Commercial Distribution

  • 00191375038870 ()

  • Footprint, Standard
  • Height: 15 Millimeter
  • For Use with Heights, 14mm to 17mm
  • Height: 16 Millimeter
  • Height: 17 Millimeter
  • Height: 14 Millimeter
2301-1417-S

  • Metallic spinal interbody fusion cage

ENDOSKELETON® TAS Sterile Barrier System - 00191375038863

Plate , Standard, 12mm to 13mm
TITAN SPINE, LLC
2301-1013-S
Not in Commercial Distribution

  • 00191375038863 ()

  • For Use with Heights, 12mm to 13mm
  • Height: 12 Millimeter
  • Footprint, Standard
  • Height: 13 Millimeter
2301-1013-S

  • Metallic spinal interbody fusion cage
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