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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DISC CLIPS
Smith & Nephew, Inc.
71061013
In Commercial Distribution

  • 00885556011744 ()
71061013

  • External orthopaedic fixation system, single-use
COMPASS KNEE ALIGNMENT STAND
Smith & Nephew, Inc.
71061012
In Commercial Distribution

  • 20885556011434 ()
  • 00885556011430 ()
71061012

  • External orthopaedic fixation system, reusable
LARGE-STANDARD COMPRESSION/DISTRACTION MODULE
Smith & Nephew, Inc.
71051012
In Commercial Distribution

  • 00885556011089 ()
71051012

  • External orthopaedic fixation system, single-use
CROSS PIN
Smith & Nephew, Inc.
110732
In Commercial Distribution

  • 00885556007303 ()
110732

  • General internal orthopaedic fixation system implantation kit
HA PIN 4.5MM THREAD DIA X 45MM X 150MM
Smith & Nephew, Inc.
71934748
In Commercial Distribution

  • 00885556288344 ()
71934748

  • Orthopaedic bone pin, non-bioabsorbable
HA PIN 4.5MM THREAD DIA X 35MM X 150MM
Smith & Nephew, Inc.
71934747
In Commercial Distribution

  • 00885556288290 ()
71934747

  • Orthopaedic bone pin, non-bioabsorbable
HA PIN 4.5MM THREAD DIA X 25MM X 150MM
Smith & Nephew, Inc.
71934746
In Commercial Distribution

  • 00885556288245 ()
71934746

  • Orthopaedic bone pin, non-bioabsorbable
HA PIN 4.5MM THREAD DIA X 15MM X 150MM
Smith & Nephew, Inc.
71934745
In Commercial Distribution

  • 00885556288191 ()
71934745

  • Orthopaedic bone pin, non-bioabsorbable
EXTRA LONG STEINMAN PIN 3.2MM X 450MM
Smith & Nephew, Inc.
71927174
Not in Commercial Distribution

  • 00885556045725 ()
71927174

  • Orthopaedic bone pin, non-bioabsorbable
FIXATION PIN 150x45x5mm HALF PIN
Smith & Nephew, Inc.
124840
In Commercial Distribution

  • 20885556009561 ()
  • 00885556009567 ()
124840

  • Orthopaedic bone pin, non-bioabsorbable
FIXATION PIN 150x50x5mm HALF PIN
Smith & Nephew, Inc.
124841
In Commercial Distribution

  • 23596010408154 ()
  • 03596010408150 ()
124841

  • Orthopaedic bone pin, non-bioabsorbable
PREDRILL FIXATION PIN 150X40X5 HALF PIN
Smith & Nephew, Inc.
124839
In Commercial Distribution

  • 23596010408147 ()
  • 03596010408143 ()
124839

  • Orthopaedic bone pin, non-bioabsorbable
COVE POINT PIN 120MMX28MMX3MM
Smith & Nephew, Inc.
71022003
In Commercial Distribution

  • 03596010171092 ()
71022003

  • Orthopaedic bone pin, non-bioabsorbable
COVE POINT PIN 120MMX22MMX3
Smith & Nephew, Inc.
71022002
In Commercial Distribution

  • 03596010171085 ()
71022002

  • Orthopaedic bone pin, non-bioabsorbable
COVE POINT PIN 120MMX16MMX3MM
Smith & Nephew, Inc.
71022001
In Commercial Distribution

  • 03596010171078 ()
71022001

  • Orthopaedic bone pin, non-bioabsorbable
INSERTA-PIN .062 X 2
Smith & Nephew, Inc.
128522
In Commercial Distribution

  • 23596010084334 ()
  • 03596010084330 ()
128522

  • Orthopaedic bone pin, non-bioabsorbable
KRANENDONK SKELETAL TRACTION PIN TROCAR PT 7.64 X0
Smith & Nephew, Inc.
128177
In Commercial Distribution

  • 03596010083234 ()
128177

  • Orthopaedic bone pin, non-bioabsorbable
Saber-C Locking Plate
ELEVATION SPINE, INC.
CLP-01
In Commercial Distribution

  • 00810017910069 ()
CLP-01

  • Spinal fixation plate, non-bioabsorbable
Screw Extractor Kit External Hex 3i/Branemark RP. Kit contains. 1 Claw Reamer Bur External Hex 3i/Branemark RP (00842092125359). 1 Reverse Cutting Bur External Hex 3i/Branemark (00842092139233). 1 Centering Device (00842092155684)
Preat Corporation
0800152
In Commercial Distribution

  • 00842092155721 ()
0800152

  • Screw extractor, single-use
IV Rod & Holder Assy f/1" Post, External Mount
Medical Technology Industries, Inc.
1000168
In Commercial Distribution

  • 10840118415061 ()
1000168

  • Freestanding/bed-attached intravenous pole
PROFIX MIS 5-IN-1 INC FLEX EXTERNAL ROT GDE RIGHT
Smith & Nephew, Inc.
71513379
Not in Commercial Distribution

  • 03596010534125 ()
71513379

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROFIX MIS 5-IN-1 INC FLEX EXTERNAL ROT GDE LEFT
Smith & Nephew, Inc.
71513369
Not in Commercial Distribution

  • 03596010534033 ()
71513369

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROFIX MIS 5-IN-1 INC FLEX EXTERNAL ROT GDE NEUT
Smith & Nephew, Inc.
71513389
Not in Commercial Distribution

  • 03596010534217 ()
71513389

  • Orthopaedic prosthesis implantation positioning instrument, reusable
JET-X LARGE - UNILATERAL EXTERNAL FIXATOR SYSTEM INNER TRAY LID
Smith & Nephew, Inc.
71067355
In Commercial Distribution

  • 03596010608093 ()
71067355

  • Instrument tray, reusable
SIMPLE TEMP.POST PEEK EXTERNAL PROF,REP,PREKOHTG MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-MPSP-M
In Commercial Distribution

  • D7700874843 ()
A-TG-MPSP-M

  • Dental implant suprastructure, permanent, preformed
SIMPLE TEMP.POST TIT. EXTERNAL PROF,REP,PREKOHTG MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-MPST-M
In Commercial Distribution

  • D7700884083 ()
A-TG-MPST-M

  • Dental implant suprastructure, permanent, preformed
Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BS-01E
In Commercial Distribution

  • 00816734022313 ()
  • B019ZANBS01E0 ()

  • Catheter Gauge: 6.4 French
ZAN-BS-01E

  • Manometric gastrointestinal motility analysis system
CODMAN® EDS 3™ CSF External Drainage System
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
821731C
In Commercial Distribution

  • 10381780518327 ()
82-1731C

  • Ventricular cerebrospinal fluid drainage catheterization kit
MoniTorr™ ICP External CSF Drainage System Replacement Bag
Integra Lifesciences Corporation
INS2100
In Commercial Distribution


  • 500ml drainage bag
INS2101

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
Hermetic™ External CSF Drainage System with Pressure Tubing
Integra Lifesciences Corporation
INS8601
In Commercial Distribution

INS8601

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
Soft-Form™ Thermo Plastic External Nasal Splint, Custom Cut
INVOTEC INTERNATIONAL, INC.
20-10121
In Commercial Distribution

  • 10818501022622 ()
  • 00818501022625 ()
20-10121

  • External nasal splint
Soft-Form™ Thermo Plastic External Nasal Splint Custom Cut
INVOTEC INTERNATIONAL, INC.
20-10120
In Commercial Distribution

  • 10818501022455 ()
  • 00818501022458 ()
20-10120

  • External nasal splint
VERTU® FIXED ANGLE SCREWDRIVER 60°, EXTERNAL SHAFT ASSEMBLY
SPINAL ELEMENTS, INC.
53046-000-03
In Commercial Distribution

  • 00840606140041 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X® SINGLE LEVEL INSERTER, EXTERNAL SHAFT, LONG
SPINAL ELEMENTS, INC.
27010-003-01
In Commercial Distribution

  • 00840606162326 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SAPPHIRE X® SINGLE LEVEL INSERTER, EXTERNAL SHAFT, SHORT
SPINAL ELEMENTS, INC.
27010-001-01
In Commercial Distribution

  • 00840606162319 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
UNIVERSAL EXTERNAL NASAL SPLINT, LARGE, GAMMA STERILIZED (6/PK)
Gyrus ACMI, LLC
70890908
In Commercial Distribution

  • 00821925030121 ()
  • 00821925034037 ()


  • External nasal splint
100:1 Contra Angle Drill, Low Speed, External Irrigation
OSTEOMED LLC
450-0234
In Commercial Distribution

  • 00845694012454 ()
450-0234

  • General internal orthopaedic fixation system implantation kit
3.25mm x 15mm Small Diameter External Hex Dental Implant
AMERICAN DENTAL IMPLANT CORPORATION
325015SD
In Commercial Distribution

  • D896325015SD0 ()
325015SD

  • Screw endosteal dental implant, two-piece
3.25mm x 13mm Small Diameter External Hex Dental Implant
AMERICAN DENTAL IMPLANT CORPORATION
325013SD
In Commercial Distribution

  • D896325013SD0 ()
325013SD

  • Screw endosteal dental implant, two-piece
3.25mm x 11.5mm Small Diameter External Hex Dental Implant
AMERICAN DENTAL IMPLANT CORPORATION
3250115SD
In Commercial Distribution

  • D8963250115SD0 ()
3250115SD

  • Screw endosteal dental implant, two-piece
3.25mm x 10mm Small Diameter External Hex Dental Implant
AMERICAN DENTAL IMPLANT CORPORATION
325010SD
In Commercial Distribution

  • D896325010SD0 ()
325010SD

  • Screw endosteal dental implant, two-piece
A box of 20 SNP CYP2C19 External Control Kits.
Spartan Bioscience Inc
01004880-ABC (20)
In Commercial Distribution

  • 00628055420101 ()
01004880-ABC (20)

  • Nucleic acid amplification mastermix kit IVD
External Short Bar Ret. Coping Screw, AFS (5 pk)
BIOHORIZONS IMPLANT SYSTEMS, INC
222-110
In Commercial Distribution

  • 00847236010935 ()


  • Dental implant suprastructure, temporary, preformed, single-use
One Piece Male External Medium Catheter W/O Tape
TELEFLEX INCORPORATED
IPN029741
In Commercial Distribution

  • 14026704660411 ()
  • 24026704660418 ()
A1500M

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
One Piece Male External Regular Catheter W/O Tape
TELEFLEX INCORPORATED
IPN029740
In Commercial Distribution

  • 14026704660404 ()
  • 24026704660401 ()
A1500

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator
Fischer Medical
Bloom2 Console
In Commercial Distribution

  • 00863019000368 ()
370344G

  • Cardiac electrophysiology stimulation system
Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator
Fischer Medical
Bloom2 Console
In Commercial Distribution

  • 00863019000351 ()
370050G

  • Cardiac electrophysiology stimulation system
Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator
Fischer Medical
Bloom2 Floater
In Commercial Distribution

  • 00863019000344 ()
370049G

  • Cardiac electrophysiology stimulation system
Bloom2 Cardiac Stimulator System: External Programmable Pacemaker Pulse Generator
Fischer Medical
Bloom2 Stimulator
In Commercial Distribution

  • 00863019000337 ()
370046G

  • Cardiac electrophysiology stimulation system
MPS® Retrograde external pressure line w/pressure transducer
QUEST MEDICAL INC
5051101
In Commercial Distribution

  • 20634624551118 ()
  • 00634624551114 ()


  • Cardioplegia solution administration kit
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