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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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COMPOMASTER - E235112C0

COMPOMASTER CRS CA KNIFE
SHOFU DENTAL CORPORATION
112C
In Commercial Distribution

  • E235112C0 ()
112C

  • Dental abrasive point, reusable

COMPOMASTER - E235111C0

COMPOMASTER CRS CA BULLET
SHOFU DENTAL CORPORATION
111C
In Commercial Distribution

  • E235111C0 ()
111C

  • Dental abrasive point, reusable

HARDIE - E23503900

CA HARDIE BLACK FL2
SHOFU DENTAL CORPORATION
0390
In Commercial Distribution

  • E23503900 ()
0390

  • Dental abrasive point, reusable

CA PORC LAMINATE KIT - E23503170

CA PORC LAMINATE KIT
SHOFU DENTAL CORPORATION
0317
In Commercial Distribution

  • E23503170 ()
0317

  • Dental abrasive point, reusable

COMPOSITE - E23503100

CA COMPOSITE POL KIT
SHOFU DENTAL CORPORATION
0310
In Commercial Distribution

  • E23503100 ()
0310

  • Dental abrasive point, reusable

CA AMALGAM POLISH KT - E23503080

CA AMALGAM POLISH KT
SHOFU DENTAL CORPORATION
0308
In Commercial Distribution

  • E23503080 ()
0308

  • Dental abrasive point, reusable

CA ENAMEL ADJ KIT - E23503070

CA ENAMEL ADJ KIT
SHOFU DENTAL CORPORATION
0307
In Commercial Distribution

  • E23503070 ()
0307

  • Dental abrasive point, reusable

COMPOSITE - E23502970

CA COMPOSITE-FINE POINT IC
SHOFU DENTAL CORPORATION
0297
In Commercial Distribution

  • E23502970 ()
0297

  • Dental abrasive point, reusable

CERAMISTE - E23502590

CA CERAMISTE UL2 WHEEL
SHOFU DENTAL CORPORATION
0259
In Commercial Distribution

  • E23502590 ()
0259

  • Dental abrasive point, reusable

CERAMISTE - E23502580

CA CERAMISTE UL2 KNIFE
SHOFU DENTAL CORPORATION
0258
In Commercial Distribution

  • E23502580 ()
0258

  • Dental abrasive point, reusable

CERAMISTE - E23502570

CA CERAMISTE UL2 BULLET
SHOFU DENTAL CORPORATION
0257
In Commercial Distribution

  • E23502570 ()
0257

  • Dental abrasive point, reusable

CERAMISTE - E23502550

CA CERAMISTE UL KNIFE
SHOFU DENTAL CORPORATION
0255
In Commercial Distribution

  • E23502550 ()
0255

  • Dental abrasive point, reusable

CERAMISTE - E23502530

CA CERAMISTE STD WHEEL
SHOFU DENTAL CORPORATION
0253
In Commercial Distribution

  • E23502530 ()
0253

  • Dental abrasive point, reusable

CERAMISTE - E23502520

CA CERAMISTE STD KNIFE
SHOFU DENTAL CORPORATION
0252
In Commercial Distribution

  • E23502520 ()
0252

  • Dental abrasive point, reusable

CERAMISTE - E23502510

CA CERAMISTE STD BULLET
SHOFU DENTAL CORPORATION
0251
In Commercial Distribution

  • E23502510 ()
0251

  • Dental abrasive point, reusable

CERAMISTE - E235251A0

CA CERAMISTE STD CUP
SHOFU DENTAL CORPORATION
251A
In Commercial Distribution

  • E235251A0 ()
251A

  • Dental abrasive point, reusable

CERAMISTE - E235259A0

CA CERAMISTE UL2 MP
SHOFU DENTAL CORPORATION
259A
In Commercial Distribution

  • E235259A0 ()
259A

  • Dental abrasive point, reusable

CERAMISTE - E235257A0

CA CERAMISTE UL2 CUP
SHOFU DENTAL CORPORATION
257A
In Commercial Distribution

  • E235257A0 ()
257A

  • Dental abrasive point, reusable

CERAMISTE - E235256A0

CA CERAMISTE UL MP
SHOFU DENTAL CORPORATION
256A
In Commercial Distribution

  • E235256A0 ()
256A

  • Dental abrasive point, reusable

CERAMISTE - E235254A0

CA CERAMISTE UL CUP
SHOFU DENTAL CORPORATION
254A
In Commercial Distribution

  • E235254A0 ()
254A

  • Dental abrasive point, reusable

Curaplex - 00810071631122

CONN.TUBE,14'*,50/CA
BOUND TREE MEDICAL, LLC
301-142
In Commercial Distribution

  • 00810071630729 ()
  • 00810071631122 ()
301-142

  • Oxygen administration tubing

Astra Tech Implant System® - 07392532002496

Slot CA Driver Long
Dentsply Implants Manufacturing GmbH
22689
In Commercial Distribution

  • 07392532002496 ()
22689

  • Surgical screwdriver, reusable

Astra Tech Implant System® - 07392532002489

Slot CA Driver Short
Dentsply Implants Manufacturing GmbH
22688
In Commercial Distribution

  • 07392532002489 ()
22688

  • Surgical screwdriver, reusable

Articulator - E1997592331

Articulator CA 3.0 LARGE
Candulor AG
759233
In Commercial Distribution

  • E1997592331 ()
759233

  • Dental articulator

Medline Industries, Inc. - 10198459187674

SYR, CA, TACE KIT
MEDLINE INDUSTRIES, INC.
VASC1643
In Commercial Distribution

  • 40198459187675 ()
  • 10198459187674 ()
VASC1643

  • General surgical procedure kit, non-medicated, single-use

Henry Schein Maxima - 00304040058015

Maxima ELITE Electric CA
HENRY SCHEIN, INC.
1125681
In Commercial Distribution

  • 00304040058015 ()
1125681

  • Dental power tool converter attachment, rotary

Henry Schein - 00304040057827

E-Type Reduction CA Sheath
HENRY SCHEIN, INC.
1026953
In Commercial Distribution

  • 00304040057827 ()
1026953

  • Dental power tool system handpiece, pneumatic

BiPAP A40 - 00606959059405

BiPAP A40 Pro, CA
Respironics, Inc.
CAX3100S12
In Commercial Distribution

  • 00606959059405 ()
CAX3100S12

  • Portable electric ventilator

ARCHITECT - 00380740145309

ARCHITECT CA 15-3 Controls
Abbott GmbH
02K4411
In Commercial Distribution

  • 00380740145309 ()
02K4411

  • Cancer antigen 15-3 (CA15-3) IVD, control

ARCHITECT - 00380740145293

ARCHITECT CA 15-3 Calibrators
Abbott GmbH
02K4402
In Commercial Distribution

  • 00380740145293 ()
02K4402

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator

DreamStation - 00606959040540

DreamStation BiPAP autoSV, CA
Respironics, Inc.
DreamStation BiPAP autoSV, CA
In Commercial Distribution

  • 00606959040540 ()
CAX900S12

  • Portable electric ventilator

IRISpec - 10837461001973

IRISpec CA/CB Twinset
IRIS INTERNATIONAL, INC.
CA/CB Twinset
Not in Commercial Distribution

  • 10837461001973 ()
800-7211

  • Multiple urine analyte IVD, control

Carbide burs - 04057176163899

Carbide CA 1,2 mm
DFS - DIAMON GmbH
103512
In Commercial Distribution

  • 04057176163882 ()
  • 04057176163899 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176162397

Carbide bone cutter CA
DFS - DIAMON GmbH
110184
In Commercial Distribution

  • 04057176162380 ()
  • 04057176162397 ()


  • Carbide dental bur, reusable

Polishers - 04057176161215

2metal polisher cup CA
DFS - DIAMON GmbH
800480
In Commercial Distribution

  • 04057176161215 ()


  • Dental polishing brush

CA diamonds - 04057176156785

Electroplated Diamond Instr. CA
DFS - DIAMON GmbH
60199168W
In Commercial Distribution

  • 04057176156778 ()
  • 04057176156785 ()


  • Diamond dental bur, reusable

Polishers - 04057176152626

Polisher Durocomp CA 6p
DFS - DIAMON GmbH
800570
In Commercial Distribution

  • 04057176152626 ()


  • Dental polishing brush

Polishers - 04057176152589

Polisher Durocomp lg.torpedo CA
DFS - DIAMON GmbH
800550
In Commercial Distribution

  • 04057176152589 ()


  • Dental polishing brush

Polishers - 04057176152091

2comp pol.point CA 6pcs
DFS - DIAMON GmbH
800806
In Commercial Distribution

  • 04057176152084 ()
  • 04057176152091 ()


  • Dental polishing brush

Polishers - 04057176152053

2comp pol.cup CA 6pcs
DFS - DIAMON GmbH
800686
In Commercial Distribution

  • 04057176152046 ()
  • 04057176152053 ()


  • Dental polishing brush

Polishers - 04057176152015

2comp pol.point CA 6pcs
DFS - DIAMON GmbH
800846
In Commercial Distribution

  • 04057176152008 ()
  • 04057176152015 ()


  • Dental polishing brush

Polishers - 04057176151933

2ceram pol.lense CA 6pcs
DFS - DIAMON GmbH
800666
In Commercial Distribution

  • 04057176151926 ()
  • 04057176151933 ()


  • Dental polishing brush

Polishers - 04057176151919

2ceram pol.cup CA 6pcs
DFS - DIAMON GmbH
800656
In Commercial Distribution

  • 04057176151902 ()
  • 04057176151919 ()


  • Dental polishing brush

Polishers - 04057176151896

2ceram pol.flame CA 6pcs
DFS - DIAMON GmbH
800646
In Commercial Distribution

  • 04057176151889 ()
  • 04057176151896 ()


  • Dental polishing brush

Softy-longlife - 04057176149428

Crown Cutter SOFTY-longlife CA
DFS - DIAMON GmbH
51145
In Commercial Distribution

  • 04057176149428 ()


  • Diamond dental bur, reusable

Softy-longlife - 04057176149381

Crown Cutter SOFTY-longlife CA
DFS - DIAMON GmbH
51143
In Commercial Distribution

  • 04057176149381 ()


  • Diamond dental bur, reusable

Softy-longlife - 04057176149374

Crown Cutter SOFTY-longlife CA
DFS - DIAMON GmbH
51141
In Commercial Distribution

  • 04057176149374 ()


  • Diamond dental bur, reusable

Bone cutters - 04057176149060

Carbide bone cutter CA
DFS - DIAMON GmbH
111414
In Commercial Distribution

  • 04057176149053 ()
  • 04057176149060 ()


  • Carbide dental bur, reusable

Bone cutters - 04057176148728

Carbide CA bone cutter
DFS - DIAMON GmbH
111513
In Commercial Distribution

  • 04057176148711 ()
  • 04057176148728 ()


  • Carbide dental bur, reusable

Polishers - 04057176161277

2metal polisher point CA
DFS - DIAMON GmbH
800440
In Commercial Distribution

  • 04057176161277 ()


  • Dental polishing brush
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