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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UNIVERSAL ALLEN WRENCH
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861341 ()
91017

  • Surgical torque wrench, reusable
SUPPLEMENTARY SCREW HOLDER
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861259 ()
90037

  • External orthopaedic fixation system, reusable
XCALIBER MANIPULATION FORCEPS
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568035216 ()
19200

  • External orthopaedic fixation system, reusable
Saber-C Locking Plate
ELEVATION SPINE, INC.
CLP-01
In Commercial Distribution

  • 00810017910069 ()
CLP-01

  • Spinal fixation plate, 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
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
KRANENDONK SKELETAL TRACTION PIN TROCAR PT 7.64 X0
Smith & Nephew, Inc.
128177
In Commercial Distribution

  • 03596010083234 ()
128177

  • Orthopaedic bone pin, 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
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
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
LIGHT CARRIER FOR LARYNGOSCOPE external, for operating laryngoscopes 824202000
Richard Wolf GmbH
824202001
Not in Commercial Distribution

  • 04055207033326 ()
824202001

  • Rigid intubation laryngoscope, reusable
MPS® Retrograde external pressure line w/pressure transducer
QUEST MEDICAL INC
5051101
In Commercial Distribution

  • 20634624551118 ()
  • 00634624551114 ()


  • Cardioplegia solution administration kit
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
4.0mm Diameter Straight External Hex Implant Length 11.5mm Sandblast
TITAN IMPLANT INC
T-4SE11S
In Commercial Distribution

  • 00842448112811 ()


  • Dental implant system
4.0mm Diameter Straight External Hex Implant Length 11.5mm RBM
TITAN IMPLANT INC
T-4SE11R
In Commercial Distribution

  • 00842448112804 ()


  • Dental implant system
4.0mm Diameter Straight External Hex Implant Length 10mm Sandblast
TITAN IMPLANT INC
T-4SE10S
In Commercial Distribution

  • 00842448112798 ()


  • Dental implant system
4.0mm Diameter Straight External Hex Implant Length 10mm RBM
TITAN IMPLANT INC
T-4SE10R
In Commercial Distribution

  • 00842448112781 ()


  • Dental implant system
3.75/4.0mm External Spline Ball Head Abutment GH 1.5mm
TITAN IMPLANT INC
TZDS-3-4BHA-1.5
In Commercial Distribution

  • 00842448112767 ()


  • Dental implant suprastructure, permanent, preformed
4.0mm, 5.0mm, & 6.0mm External Hex Implant Fixture Mount Screw
TITAN IMPLANT INC
T-FMS4
In Commercial Distribution

  • 00842448112132 ()


  • Dental prosthesis/implant abutment screw
4.1mm External Hex Straight Locking Temporary Abutment GH 1mm
TITAN IMPLANT INC
T-4SLTA-02-1.0
In Commercial Distribution

  • 00842448110961 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.1mm External Hex Post Abutment Bite Registration GH 4mm
TITAN IMPLANT INC
T-4PABR-04
In Commercial Distribution

  • 00842448110732 ()


  • Dental implant suprastructure, permanent, preformed
4.1mm External Hex Post Abutment Bite Registration GH 2mm
TITAN IMPLANT INC
T-4PABR-02
In Commercial Distribution

  • 00842448110725 ()


  • Dental implant suprastructure, permanent, preformed
4.1mm External Hex Implant Impression Coping Profile Dia: 6.0mm
TITAN IMPLANT INC
T-4IIC-B
In Commercial Distribution

  • 00842448110565 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.1mm External Hex Implant Impression Coping Profile Dia: 5.0mm
TITAN IMPLANT INC
T-4IIC-A
In Commercial Distribution

  • 00842448110558 ()


  • Dental implant suprastructure, temporary, preformed, single-use
4.3mm External Hex Implant Impression Coping Profile Dia: 6.0mm
TITAN IMPLANT INC
SR2-43IIC
In Commercial Distribution

  • 00842448107381 ()


  • Dental implant suprastructure, temporary, preformed, single-use
3.75/4.0mm External Spline Implant Healing Abutment Gh 7.0mm
TITAN IMPLANT INC
C-3.75/4HA-A-7.0
In Commercial Distribution

  • 00842448101778 ()


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