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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MAXCUT DIAMOND BURS (6/pk) Shape: Pointed Cylinder; Size (in 1/10mm): 012; Grit: Coarse; For more information: https://www.scottsdental.com/burs/diamond-burs/pointed-cylinder-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-6884-12
In Commercial Distribution

  • D7781006884120 ()
  • D7781006884121 ()
100-6884-12

  • Diamond dental bur, reusable
MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size: 8; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/
SCOTT'S DENTAL SUPPLY L.L.C.
111-1978
In Commercial Distribution

  • D77811119780 ()
  • D77811119781 ()
111-1978

  • Carbide dental bur, single-use
MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size: 6; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/
SCOTT'S DENTAL SUPPLY L.L.C.
111-1976
In Commercial Distribution

  • D77811119760 ()
  • D77811119761 ()
111-1976

  • Carbide dental bur, single-use
MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size: 4; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/
SCOTT'S DENTAL SUPPLY L.L.C.
111-1974
In Commercial Distribution

  • D77811119740 ()
  • D77811119741 ()
111-1974

  • Carbide dental bur, single-use
MAXCUT CARBIDE BUR (100/pk) Shape: Round; Size: 2; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/
SCOTT'S DENTAL SUPPLY L.L.C.
111-1972
In Commercial Distribution

  • D77811119720 ()
  • D77811119721 ()
111-1972

  • Carbide dental bur, single-use
MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: 8; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/
SCOTT'S DENTAL SUPPLY L.L.C.
111-1491
In Commercial Distribution

  • D77811114910 ()
  • D77811114911 ()
111-1491

  • Carbide dental bur, single-use
MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: 6; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/
SCOTT'S DENTAL SUPPLY L.L.C.
111-1485
In Commercial Distribution

  • D77811114850 ()
  • D77811114851 ()
111-1485

  • Carbide dental bur, single-use
MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: 4; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/
SCOTT'S DENTAL SUPPLY L.L.C.
111-1479
In Commercial Distribution

  • D77811114790 ()
  • D77811114791 ()
111-1479

  • Carbide dental bur, single-use
MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: 2; Shank: Latch; For more information: https://www.scottsdental.com/catalog/product/view/id/17301/s/ra-latch-carbide-burs-maxcut/
SCOTT'S DENTAL SUPPLY L.L.C.
111-1477
In Commercial Distribution

  • D77811114770 ()
  • D77811114771 ()
111-1477

  • Carbide dental bur, single-use
COAG ELECTRODE MONO 21FR 30° for resectoscopes, telescope Ø 3.3mm, for sheaths, intermittent/continuous irrigation, 21/24, Fr, electrode shape: ball, fork color red, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
8656802
Not in Commercial Distribution

  • 04055207019047 ()

  • Angle: 30 degree
  • Outer Diameter: 7 Millimeter
8656.802

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
HOOK ELECTRODE MONO 22-26FR 0° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 22/24/25.5/26/28, Fr, electrode shape: hook, stem color red, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
842009
Not in Commercial Distribution

  • 04055207010136 ()

  • Angle: 0 degree
8420.09

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
EVAP-ELECTRODE MONO 24-26FR 0° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 24/26/27, Fr, electrode shape: barrel, fork color green, stem color blue, PACK=1 PC, for E-Line resectoscope, unsterile, reusable
Richard Wolf GmbH
8410031
Not in Commercial Distribution

  • 04055207017029 ()

  • Angle: 0 degree
8410.031

  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
KNIFE ELECTRODE MONO 22-24FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24/26 Fr, electrode shape: knife, fork color green, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use
Richard Wolf GmbH
46782204
In Commercial Distribution

  • 04055207053461 ()
  • 04055207053478 ()
46782204

  • Endoscopic electrosurgical electrode, monopolar, single-use
COAG ELECTRODE MONO 22-24FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24/26 Fr, electrode shape: button, fork color green, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use
Richard Wolf GmbH
46782203
In Commercial Distribution

  • 04055207053447 ()
  • 04055207053454 ()
46782203

  • Endoscopic electrosurgical electrode, monopolar, single-use
COAG ELECTRODE MONO 22-24FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24/26 Fr, electrode shape: ball, fork color green, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use
Richard Wolf GmbH
46782202
In Commercial Distribution

  • 04055207053423 ()
  • 04055207053430 ()
46782202

  • Endoscopic electrosurgical electrode, monopolar, single-use
HOOK ELECTRODE MONO 22-25FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 22/24/24.5/25.5, Fr, electrode shape: hook, fork color transparent, stem color red, PACK=5 PCS, for E-Line resectoscope, sterile, for single use
Richard Wolf GmbH
48423095
Not in Commercial Distribution

  • 04055207049082 ()
  • 04055207050224 ()
48423.095

  • Endoscopic electrosurgical electrode, monopolar, single-use
HOOK ELECTRODE MONO 24FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24/26 Fr, electrode shape: hook, fork color green, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use
Richard Wolf GmbH
46782205
In Commercial Distribution

  • 04055207049013 ()
  • 04055207050156 ()

  • Outer Diameter: 8 Millimeter
46782205

  • Endoscopic electrosurgical electrode, monopolar, single-use
COAG ELECTRODE MONO 22-24FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 22/24/26 Fr, electrode shape: roller, fork color green, stem color transparent, PACK = 5 PCS, for Shark Resectoscope, sterile, for single use
Richard Wolf GmbH
46782201
In Commercial Distribution

  • 04055207049006 ()
  • 04055207050149 ()
46782201

  • Endoscopic electrosurgical electrode, monopolar, single-use
BIVAP ELECTRODE BIPO 24-26FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, intermittent/continuous irrigation, 24/26 Fr, electrode shape: torus, fork color blue, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use
Richard Wolf GmbH
46300243
In Commercial Distribution

  • 04055207048948 ()
  • 04055207050088 ()
46300243

  • Endoscopic electrosurgical electrode, bipolar, single-use
BIVAP ELECTRODE BIPO 22FR 12/30° for resectoscopes, telescope Ø 4 mm, for sheaths, continuous irrigation, 22/24 Fr, electrode shape: torus, fork color blue, stem color blue, PACK=3 PCS, for Shark and S-Line Resectoscopes, sterile, for single use
Richard Wolf GmbH
46300223
In Commercial Distribution

  • 04055207048931 ()
  • 04055207050071 ()

  • Outer Diameter: 7.33333333333 Millimeter
46300223

  • Endoscopic electrosurgical electrode, bipolar, single-use
joimax® Endoscopic Trolley small
Joimax GmbH
JEST1390N
Not in Commercial Distribution

  • 04056634002237 ()

  • Separate trolley for joimax® Intracs em
JEST1390N

  • Medical monitor/light mount
joimax® Vitegra® DICOM module
Joimax GmbH
ICS0401D
In Commercial Distribution

  • 04250337119685 ()

  • License key for enabling the DICOM functionality
ICS0401D

  • Medical image management system
digit Power Dispenser Wireless - Foot Control
DENTSPLY INTERNATIONAL INC.
678537
Not in Commercial Distribution

  • D0026785371 ()

  • 1x Foot Control for digit Power Dispenser
678537

  • Dental material cartridge-plunging applicator, two-component, electric
Dispo Infusor, for single use
VBM Medizintechnik GmbH
56-02-100
Not in Commercial Distribution

  • 14250105608349 ()
  • 04250105608342 ()

  • for rapid pressure infusion and irrigation purposes
  • Total Volume: 1000 Milliliter


  • Intravenous pressure infusor, manual, reusable
Dispo Infusor for single use
VBM Medizintechnik GmbH
56-01-050
Not in Commercial Distribution

  • 14250105608301 ()
  • 04250105608304 ()

  • for rapid pressure infusion and irrigation purposes
  • Total Volume: 500 Milliliter


  • Intravenous pressure infusor, manual, reusable
Infusor 500
VBM Medizintechnik GmbH
57-08-050
Not in Commercial Distribution

  • 04250105605433 ()

  • for rapid pressure infusion and irrigation purposes
  • Total Volume: 500 Milliliter


  • Intravenous pressure infusor, manual, reusable
Infusor 1000
VBM Medizintechnik GmbH
57-02-100
Not in Commercial Distribution

  • 04250105605426 ()

  • for rapid pressure infusion and irrigation purposes
  • Total Volume: 1000 Milliliter


  • Intravenous pressure infusor, manual, reusable
Infusor 500
VBM Medizintechnik GmbH
57-02-050
Not in Commercial Distribution

  • 04250105605419 ()

  • for rapid pressure infusion and irrigation purposes
  • Total Volume: 500 Milliliter


  • Intravenous pressure infusor, manual, reusable
Fixation Tape
VBM Medizintechnik GmbH
35-40-633
Not in Commercial Distribution

  • 14250105601197 ()
  • 04250105601190 ()

  • Accessory for VBM Endoscopy Mask #3, #5


  • Endotracheal tube holder
Tap 5.5mm, Tri-Flat, Cannulated (for 6.0mm Screw)
Seaspine Orthopedics Corporation
97-6324
In Commercial Distribution

  • 10889981153045 ()

  • Tap 5.5mm, Tri-Flat, Cannulated (for 6.0mm Screw)
97-6324

  • Bone tap, reusable
Tap 5.0mm, Tri-Flat, Cannulated (for 5.5mm Screw)
Seaspine Orthopedics Corporation
97-6323
In Commercial Distribution

  • 10889981153038 ()

  • Tap 5.0mm, Tri-Flat, Cannulated (for 5.5mm Screw)
97-6323

  • Bone tap, reusable
3 drills for 1.10 mm fiber post.
Ilumi Sciences, Inc.
DR-0110
In Commercial Distribution

  • 00850692005339 ()

  • 3 drills for 1.10 mm fiber pos


  • Pin/post dental drill bit
3 drills for 1.67 mm fiber post.
Ilumi Sciences, Inc.
DR-0167
In Commercial Distribution

  • 00850692005087 ()

  • 3 drills for 1.67 mm fiber post


  • Pin/post dental drill bit
3 Drills for 1.47 mm fiber post.
Ilumi Sciences, Inc.
DR-0147
In Commercial Distribution

  • 00850692005070 ()

  • 3 Drills for 1.47 mm fiber post


  • Pin/post dental drill bit
3 drills for 1.35 mm fiber post.
Ilumi Sciences, Inc.
DR-0135
In Commercial Distribution

  • 00850692005063 ()

  • 3 drills for 1.35 mm fiber post


  • Pin/post dental drill bit
Acetabular Cup (Ti6Al4V) Dia. 44 mm, for Liners size SMALL
LIMACORPORATE SPA
5553.14.441
In Commercial Distribution

  • 08033390146098 ()

  • Dia. 44 mm, for Liners size SMALL
5553.14.441

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 46 mm, for Liners size MEDIUM -
LIMACORPORATE SPA
5553.14.462
In Commercial Distribution

  • 08033390146074 ()

  • Dia. 46 mm, for Liners size MEDIUM -
5553.14.462

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 48 mm, for Liners size MEDIUM -
LIMACORPORATE SPA
5553.14.482
In Commercial Distribution

  • 08033390146067 ()

  • Dia. 48 mm, for Liners size MEDIUM -
5553.14.482

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 50 mm, for Liners size MEDIUM +
LIMACORPORATE SPA
5553.14.503
In Commercial Distribution

  • 08033390146043 ()

  • Dia. 50 mm, for Liners size MEDIUM +
5553.14.503

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 52 mm, for Liners size MEDIUM +
LIMACORPORATE SPA
5553.14.523
In Commercial Distribution

  • 08033390146036 ()

  • Dia. 52 mm, for Liners size MEDIUM +
5553.14.523

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 54 mm, for Liners size MEDIUM +
LIMACORPORATE SPA
5553.14.543
In Commercial Distribution

  • 08033390146029 ()

  • Dia. 54 mm, for Liners size MEDIUM +
5553.14.543

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 56 mm, for Liners size LARGE+
LIMACORPORATE SPA
5553.14.564
In Commercial Distribution

  • 08033390146005 ()

  • Dia. 56 mm, for Liners size LARGE+
5553.14.564

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 58 mm, for Liners size LARGE+
LIMACORPORATE SPA
5553.14.584
In Commercial Distribution

  • 08033390145992 ()

  • Dia. 58 mm, for Liners size LARGE+
5553.14.584

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 60 mm, for Liners size EXTRA-LARGE
LIMACORPORATE SPA
5553.14.605
In Commercial Distribution

  • 08033390145978 ()

  • Dia. 60 mm, for Liners size EXTRA-LARGE
5553.14.605

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 62 mm, for Liners size EXTRA-LARGE
LIMACORPORATE SPA
5553.14.625
In Commercial Distribution

  • 08033390145961 ()

  • Dia. 62 mm, for Liners size EXTRA-LARGE
5553.14.625

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 64 mm, for Liners size EXTRA-LARGE
LIMACORPORATE SPA
5553.14.645
In Commercial Distribution

  • 08033390145954 ()

  • Dia. 64 mm, for Liners size EXTRA-LARGE
5553.14.645

  • Metallic acetabulum prosthesis
Acetabular Cup (Ti6Al4V) Dia. 66 mm, for Liners size EXTRA-LARGE
LIMACORPORATE SPA
5553.14.665
In Commercial Distribution

  • 08033390145947 ()

  • Dia. 66 mm, for Liners size EXTRA-LARGE
5553.14.665

  • Metallic acetabulum prosthesis
ITO HC 3.5 (CB) - Delrin Healing Cap for 3.5 One-Piece (CB)
Suncoast Dental, Inc
Delrin Healing Cap for 3.5 One-Piece (CB)
Not in Commercial Distribution

  • 00083208100352 ()

  • 3.5 Delrin Healing Cap for One-Piece (CB)
  • Outer Diameter: 3.5 Millimeter
ITO HC 3.5 (CB)

  • Dental implant suprastructure kit
ITO HC 3.0 (CB) - Delrin Healing Cap for 3.0 One-Piece (CB)
Suncoast Dental, Inc
Delrin Healing Cap for 3.0 One-Piece (CB)
Not in Commercial Distribution

  • 00083208100307 ()

  • 3.0 Delrin Healing Cap for One-Piece (CB)
  • Outer Diameter: 3 Millimeter
ITO HC 3.0 (CB)

  • Dental implant suprastructure kit
Integrity HCS Cover Screw for 6.0-8.0 Implants
Suncoast Dental, Inc
6.0-8.0 HCS Integrity Cover Screw
In Commercial Distribution

  • 00083208608070 ()

  • Integrity HCS Cover Screw for 6.0-8.0 Implants
  • Outer Diameter: 6 Millimeter
HCS ITI Cover Screw 6.0-8.0

  • Dental implant suprastructure, temporary, preformed, single-use
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