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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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HEARTRAIL - 04987350383099

HEARTRAIL III Guiding Catheter
TERUMO CORPORATION
40-6371
In Commercial Distribution

  • 54987350383094 ()
  • 04987350383099 ()

  • Pressure: 4826 KiloPascal
  • Shape name of distal shaft is IL3.5(SH)
  • Outer Diameter: 2.06 Millimeter
  • Length: 100 Centimeter
  • Lumen/Inner Diameter: 1.80 Millimeter
GC-U6IL350A

  • Vascular guide-catheter, single-use

Brella - 00860009462229

Ten count (CB-1067) a skin patch for the treatment of hyperhidrosis in a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis
Candesant Biomedical, Inc.
CB-1050
In Commercial Distribution

  • 00860009462229 ()
  • 00860009462267 ()

  • Oval shape with width 2.75" and length 5"
CB-1050

  • Antiperspirant

Brella - 00860009462205

A skin patch for treatment of hyperhidrosis in a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis.
Candesant Biomedical, Inc.
CB-1067
In Commercial Distribution

  • 00860009462205 ()

  • Oval shape with width 2.75" and length 5"
CB-1067

  • Antiperspirant

Contours™ Coarse Anatomy Trimmers Shape 08 - 07540172001458

Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078208
In Commercial Distribution

  • 07540172001458 ()
078208

  • Dental abrasive point, reusable

Contours™ Coarse Anatomy Trimmers Shape 06 - 07540172001441

Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078206
In Commercial Distribution

  • 07540172001441 ()
078206

  • Dental abrasive point, reusable

Contours™ Coarse Anatomy Trimmers Shape 05 - 07540172001434

Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078205
In Commercial Distribution

  • 07540172001434 ()
078205

  • Dental abrasive point, reusable

Contours™ Coarse Anatomy Trimmers Shape 04 - 07540172001427

Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078204
In Commercial Distribution

  • 07540172001427 ()
078204

  • Dental abrasive point, reusable

Contours™ Coarse Anatomy Trimmers Shape 02 - 07540172001410

Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078202
Not in Commercial Distribution

  • 07540172001410 ()
078202

  • Dental abrasive point, reusable

Contours™ Coarse Anatomy Trimmers Shape 01 - 07540172001403

Dental Mandrel
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
078201
Not in Commercial Distribution

  • 07540172001403 ()
078201

  • Dental abrasive point, reusable

Contours™ Coarse Anatomy Trimmers Shape 08 - 00359883003104

Dental Mandrel
DEN-MAT HOLDINGS, LLC
078208
In Commercial Distribution

  • 00359883003104 ()
078208

  • Dental abrasive point, reusable

Contours™ Coarse Anatomy Trimmers Shape 06 - 00359883003098

Dental Mandrel
DEN-MAT HOLDINGS, LLC
078206
In Commercial Distribution

  • 00359883003098 ()
078206

  • Dental abrasive point, reusable

Contours™ Coarse Anatomy Trimmers Shape 05 - 00359883003081

Dental Mandrel
DEN-MAT HOLDINGS, LLC
078205
In Commercial Distribution

  • 00359883003081 ()
078205

  • Dental abrasive point, reusable

MicroLap "S" Shape Dissector, Jaw Insert 200mm - E496LILIP2DS200

No Description
AB MEDICA
LIL-IP-2DS-20
In Commercial Distribution

  • E496LILIP2DS200 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable

"S" shape dissector L=50cm D=5mm - E496C05IP2DS500

No Description
AB MEDICA
C05-IP-2DS-50
In Commercial Distribution

  • E496C05IP2DS500 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable

"S" shape dissector L=35cm D=5mm - E496C05IP2DS350

No Description
AB MEDICA
C05-IP-2DS-35
In Commercial Distribution

  • E496C05IP2DS350 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable

"C" shape dissector L=50cm D=5mm - E496C05IP2DC500

No Description
AB MEDICA
C05-IP-2DC-50
In Commercial Distribution

  • E496C05IP2DC500 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable

"C" shape dissector L=35cm D=5mm - E496C05IP2DC350

No Description
AB MEDICA
C05-IP-2DC-35
In Commercial Distribution

  • E496C05IP2DC350 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape - EJKP100003334A0

No Description
JK-Products GmbH
JK 98 / 48-0
In Commercial Distribution

  • EJKP100003334A0 ()


  • Vibration platform exerciser, stationary
  • Ultraviolet tanning device

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape - EJKP100003333A0

No Description
JK-Products GmbH
JK 98 / 48-0
In Commercial Distribution

  • EJKP100003333A0 ()


  • Vibration platform exerciser, stationary
  • Ultraviolet tanning device

NuGrip® CMC Implant System - 10381780244332

Integra® NuGrip® The axial cannulated cutter is used to cut and shape the bone for the implant to be placed.
Ascension Orthopedics, Inc.
CUT443S
In Commercial Distribution

  • M269CUT443S1 ()
  • 10381780244332 ()

  • 2.38in L x .139in H; .202in diameter x .161in depth; reamer
CUT-443-S

  • Bone cutter

NuGrip® CMC Implant System - 10381780244325

Integra® NuGrip® The axial cannulated cutter is used to cut and shape the bone for the implant to be placed.
Ascension Orthopedics, Inc.
CUT443M
In Commercial Distribution

  • M269CUT443M1 ()
  • 10381780244325 ()

  • 2.38in L x .139in H; .229in diameter x .183in depth; reamer
CUT-443-M

  • Bone cutter

NuGrip® CMC Implant System - 10381780244318

Integra® NuGrip® The axial cannulated cutter is used to cut and shape the bone for the implant to be placed.
Ascension Orthopedics, Inc.
CUT443L
In Commercial Distribution

  • M269CUT443L1 ()
  • 10381780244318 ()

  • 2.38in L x .139in H; .261in diameter x .208in depth; reamer
CUT-443-L

  • Bone cutter

MAXCUT DIAMOND BURS (6/pk) FINE 8863L-013 - D7781008863L131

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 013; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8863L-13
In Commercial Distribution

  • D7781008863L130 ()
  • D7781008863L131 ()
100-8863L-13

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8863-016 - D7781008863161

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 016; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8863-16
In Commercial Distribution

  • D7781008863160 ()
  • D7781008863161 ()
100-8863-16

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8862-025 - D7781008862251

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 025; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8862-25
In Commercial Distribution

  • D7781008862250 ()
  • D7781008862251 ()
100-8862-25

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8862-021 - D7781008862211

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 021; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8862-21
In Commercial Distribution

  • D7781008862210 ()
  • D7781008862211 ()
100-8862-21

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8862-018 - D7781008862181

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 018; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8862-18
In Commercial Distribution

  • D7781008862180 ()
  • D7781008862181 ()
100-8862-18

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8862-016 - D7781008862161

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 016; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8862-16
In Commercial Distribution

  • D7781008862160 ()
  • D7781008862161 ()
100-8862-16

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8862-012 - D7781008862121

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 012; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8862-12
In Commercial Distribution

  • D7781008862120 ()
  • D7781008862121 ()
100-8862-12

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8862-010 - D7781008862101

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 010; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8862-10
In Commercial Distribution

  • D7781008862100 ()
  • D7781008862101 ()
100-8862-10

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8861-014 - D7781008861141

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 014; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8861-14
In Commercial Distribution

  • D7781008861140 ()
  • D7781008861141 ()
100-8861-14

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8860-014 - D7781008860141

MAXCUT DIAMOND BURS (6/pk) Shape: Flame; Size (in 1/10mm): 014; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/flame-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8860-14
In Commercial Distribution

  • D7781008860140 ()
  • D7781008860141 ()
100-8860-14

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8859-018 - D7781008859181

MAXCUT DIAMOND BURS (6/pk) Shape: Needle; Size (in 1/10mm): 018; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/needle-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8859-18
In Commercial Distribution

  • D7781008859180 ()
  • D7781008859181 ()
100-8859-18

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8859-016 - D7781008859161

MAXCUT DIAMOND BURS (6/pk) Shape: Needle; Size (in 1/10mm): 016; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/needle-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8859-16
In Commercial Distribution

  • D7781008859160 ()
  • D7781008859161 ()
100-8859-16

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8859-010 - D7781008859101

MAXCUT DIAMOND BURS (6/pk) Shape: Needle; Size (in 1/10mm): 010; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/needle-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8859-10
In Commercial Distribution

  • D7781008859100 ()
  • D7781008859101 ()
100-8859-10

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8392-016 - D7781008392161

MAXCUT DIAMOND BURS (6/pk) Shape: Interproximal; Size (in 1/10mm): 016; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/interproximal-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8392-16
In Commercial Distribution

  • D7781008392160 ()
  • D7781008392161 ()
100-8392-16

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8379-023 - D7781008379231

MAXCUT DIAMOND BURS (6/pk) Shape: Football; Size (in 1/10mm): 023; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/football-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8379-23
In Commercial Distribution

  • D7781008379230 ()
  • D7781008379231 ()
100-8379-23

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8379-018 - D7781008379181

MAXCUT DIAMOND BURS (6/pk) Shape: Football; Size (in 1/10mm): 018; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/football-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8379-18
In Commercial Distribution

  • D7781008379180 ()
  • D7781008379181 ()
100-8379-18

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) FINE 8368-022 - D7781008368221

MAXCUT DIAMOND BURS (6/pk) Shape: Football; Size (in 1/10mm): 022; Grit: Fine; For more information: https://www.scottsdental.com/burs/diamond-burs/football-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-8368-22
In Commercial Distribution

  • D7781008368220 ()
  • D7781008368221 ()
100-8368-22

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 830-016 - D778100830161

MAXCUT DIAMOND BURS (6/pk) Shape: Pear; Size (in 1/10mm): 016; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/pear-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-830-16
In Commercial Distribution

  • D778100830160 ()
  • D778100830161 ()
100-830-16

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 830-014 - D778100830141

MAXCUT DIAMOND BURS (6/pk) Shape: Pear; Size (in 1/10mm): 014; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/pear-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-830-14
In Commercial Distribution

  • D778100830140 ()
  • D778100830141 ()
100-830-14

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 830-012 - D778100830121

MAXCUT DIAMOND BURS (6/pk) Shape: Pear; Size (in 1/10mm): 012; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/pear-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-830-12
In Commercial Distribution

  • D778100830120 ()
  • D778100830121 ()
100-830-12

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 830-010 - D778100830101

MAXCUT DIAMOND BURS (6/pk) Shape: Pear; Size (in 1/10mm): 010; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/pear-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-830-10
In Commercial Distribution

  • D778100830100 ()
  • D778100830101 ()
100-830-10

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 818-052 - D778100818521

MAXCUT DIAMOND BURS (6/pk) Shape: Wheel; Size (in 1/10mm): 052; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/wheel-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-818-52
In Commercial Distribution

  • D778100818520 ()
  • D778100818521 ()
100-818-52

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 818-040 - D778100818401

MAXCUT DIAMOND BURS (6/pk) Shape: Wheel; Size (in 1/10mm): 040; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/wheel-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-818-40
In Commercial Distribution

  • D778100818400 ()
  • D778100818401 ()
100-818-40

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 818-029 - D778100818291

MAXCUT DIAMOND BURS (6/pk) Shape: Wheel; Size (in 1/10mm): 029; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/wheel-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-818-29
In Commercial Distribution

  • D778100818290 ()
  • D778100818291 ()
100-818-29

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 813-017 - D778100813171

MAXCUT DIAMOND BURS (6/pk) Shape: Amalgam; Size (in 1/10mm): 017; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/amalgam-remover-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-813-17
In Commercial Distribution

  • D778100813170 ()
  • D778100813171 ()
100-813-17

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 813-015 - D778100813151

MAXCUT DIAMOND BURS (6/pk) Shape: Amalgam; Size (in 1/10mm): 015; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/amalgam-remover-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-813-15
In Commercial Distribution

  • D778100813150 ()
  • D778100813151 ()
100-813-15

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 813-014 - D778100813141

MAXCUT DIAMOND BURS (6/pk) Shape: Amalgam; Size (in 1/10mm): 014; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/amalgam-remover-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-813-14
In Commercial Distribution

  • D778100813140 ()
  • D778100813141 ()
100-813-14

  • Diamond dental bur, reusable

MAXCUT DIAMOND BURS (6/pk) MED 813-012 - D778100813121

MAXCUT DIAMOND BURS (6/pk) Shape: Amalgam; Size (in 1/10mm): 012; Grit: Medium; For more information: https://www.scottsdental.com/burs/diamond-burs/amalgam-remover-multi-use-diamond-burs-maxcut.html
SCOTT'S DENTAL SUPPLY L.L.C.
100-813-12
In Commercial Distribution

  • D778100813120 ()
  • D778100813121 ()
100-813-12

  • Diamond dental bur, reusable
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