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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MALLET WITH NYLON ENDS
Smith & Nephew, Inc.
72200867
In Commercial Distribution

  • 03596010579324 ()
72200867

  • Surgical mallet
KNEE BALANCER DRIVER
Smith & Nephew, Inc.
71442155
In Commercial Distribution

  • 03596010566713 ()
71442155

  • Orthopaedic knee-balance analyser, non-electrical
SI SCREWDRIVER, STANDARD
HYHTE HOLDINGS, INC.
RZA090000
In Commercial Distribution

  • 00840085262906 ()
RZA090000

  • Surgical screwdriver, reusable
SI SCREW DRILL, NAVIGATED, Ø11MM
HYHTE HOLDINGS, INC.
RZA061110
In Commercial Distribution

  • 00840085262715 ()
RZA061110

  • Manual wire driver
SI SCREW DRILL, NAVIGATED, Ø7MM
HYHTE HOLDINGS, INC.
RZA061070
In Commercial Distribution

  • 00840085262692 ()
RZA061070

  • Manual wire driver
SI SCREW DRILL, STANDARD, Ø11MM
HYHTE HOLDINGS, INC.
RZA060110
In Commercial Distribution

  • 00840085262678 ()
RZA060110

  • Manual wire driver
SI SCREW DRILL, STANDARD, Ø7MM
HYHTE HOLDINGS, INC.
RZA060070
In Commercial Distribution

  • 00840085262654 ()
RZA060070

  • Manual wire driver
BONE PIN DRIVER
HYHTE HOLDINGS, INC.
KZH140000
In Commercial Distribution

  • 00840085261879 ()


  • Self-retaining surgical retractor, reusable
BLADE DRIVER
HYHTE HOLDINGS, INC.
KZH120000
In Commercial Distribution

  • 00840085261596 ()


  • Self-retaining surgical retractor, reusable
CARRIAGE DRIVER
HYHTE HOLDINGS, INC.
KZH080000
In Commercial Distribution

  • 00840085261558 ()
KZH080000

  • Self-retaining surgical retractor, reusable
FRAME DRIVER
HYHTE HOLDINGS, INC.
KZH060000
In Commercial Distribution

  • 00840085261534 ()
KZH060000

  • Self-retaining surgical retractor, reusable
T27 STICK FIT SCREW SHANK DRIVER
HYHTE HOLDINGS, INC.
NZA004000
In Commercial Distribution

  • 00840085260957 ()
NZA004000

  • Surgical screwdriver, reusable
T27 SCREW HEIGHT ADJUSTER
HYHTE HOLDINGS, INC.
NZA008000
In Commercial Distribution

  • 00840085260940 ()
NZA008000

  • Surgical screwdriver, reusable
SCREW SHANK DRIVER, CANNULATED
HYHTE HOLDINGS, INC.
NZA003001
In Commercial Distribution

  • 00840085258510 ()
NZA003001

  • Surgical screwdriver, reusable
MONOAXIAL SCREW DRIVER
HYHTE HOLDINGS, INC.
NZA002008
In Commercial Distribution

  • 00840085257742 ()
NZA002008

  • Surgical screwdriver, reusable
NAVIGATED, HIGH TOP, SCREW DRIVER
HYHTE HOLDINGS, INC.
NZA002006
In Commercial Distribution

  • 00840085257728 ()
NZA002006

  • Surgical screwdriver, reusable
HIGH TOP SCREW DRIVER
HYHTE HOLDINGS, INC.
NZA002004
In Commercial Distribution

  • 00840085257704 ()
NZA002004

  • Surgical screwdriver, reusable
NAVIGATED, SCREW DRIVER
HYHTE HOLDINGS, INC.
NZA002002
In Commercial Distribution

  • 00840085257681 ()
NZA002002

  • Surgical screwdriver, reusable
SCREW DRIVER
HYHTE HOLDINGS, INC.
NZA002000
In Commercial Distribution

  • 00840085257667 ()
NZA002000

  • Surgical screwdriver, reusable
Set Screw Inserter, Long
ALPHATEC SPINE, INC.
19814
In Commercial Distribution

  • 00190376301877 ()


  • Surgical screwdriver, reusable
DRIVER CANNULATED 2MM
Smith & Nephew, Inc.
7207193
In Commercial Distribution

  • 03596010253491 ()
7207193

  • Orthopaedic implant driver
Reform® Ti Locking Polyaxial Driver
PRECISION SPINE, INC.
75-RT-0700
In Commercial Distribution

  • 00840019975711 ()
75-RT-0700

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Reform® Ti Reduction Driver, Cannulated
PRECISION SPINE, INC.
70-RT-1730
In Commercial Distribution

  • 00840019975704 ()
70-RT-1730

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Reform® MAX Modular Driver BOM (GLOBOT)
PRECISION SPINE, INC.
73-BK-0105
In Commercial Distribution

  • 00840019973076 ()
73-BK-0105

  • Neurosurgical retraction system, spinal
Reform® MAX Modular Driver BOM (GLOBOT)
PRECISION SPINE, INC.
73-BK-0103
In Commercial Distribution

  • 00840019973052 ()
73-BK-0103

  • Neurosurgical retraction system, spinal
Modular T25 Driver
PRECISION SPINE, INC.
73-MD-2800
In Commercial Distribution

  • 00840019972901 ()
73-MD-2800

  • Neurosurgical retraction system, spinal
Polyaxial Driver, Cannulated
PRECISION SPINE, INC.
70-CT-1700
In Commercial Distribution

  • 00840019970976 ()
70-CT-1700

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Modular Driver, Reform Ti, Cannulated
PRECISION SPINE, INC.
75-RT-1800
In Commercial Distribution

  • 00840019970754 ()
75-RT-1800

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Locking Polyaxial Driver, Reform Ti, Cannulated
PRECISION SPINE, INC.
75-RT-1700
In Commercial Distribution

  • 00840019970730 ()
75-RT-1700

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Modular Screw Driver
PRECISION SPINE, INC.
70-MC-0820
In Commercial Distribution

  • 00840019970662 ()
70-MC-0820

  • Orthopaedic surgical procedure kit, non-medicated, reusable
PROFIX 3/16IN HEX SCREWDRIVER
Smith & Nephew, Inc.
71512574
In Commercial Distribution

  • 03596010224323 ()
71512574

  • Surgical screwdriver, reusable
PROFIX 750 GRAMS MALLET
Smith & Nephew, Inc.
71512452
In Commercial Distribution

  • 03596010223890 ()
71512452

  • Surgical mallet
Cannulated Reduction Polyaxial Screw Driver, NI
ALPHATEC SPINE, INC.
87781
In Commercial Distribution

  • 00190376003702 ()


  • Surgical screwdriver, reusable
Cannulated Polyaxial Screw Driver, NI
ALPHATEC SPINE, INC.
87778
In Commercial Distribution

  • 00190376003337 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Polyaxial Screw Driver, NI
ALPHATEC SPINE, INC.
73767
In Commercial Distribution

  • 00190376002484 ()


  • Surgical screwdriver, reusable
SLAP HAMMER
Smith & Nephew, Inc.
71364010
In Commercial Distribution

  • 03596010199263 ()
71364010

  • Surgical mallet
COFIELD2 SLOTTED HAMMER
Smith & Nephew, Inc.
71249915
Not in Commercial Distribution

  • 03596010189509 ()
71249915

  • Surgical mallet
CALANDRUCCIO II 1/2IN HEX T-DRIVER
Smith & Nephew, Inc.
71040006
In Commercial Distribution

  • 03596010410405 ()
71040006

  • Surgical screwdriver, reusable
DYONICS POWER WIRE DRIVER
Smith & Nephew, Inc.
7205789
In Commercial Distribution

  • 03596010409003 ()
7205789

  • Surgical power tool system handpiece, wire-driving, rechargeable battery-powered
LARGE SLAP HAMMER
Smith & Nephew, Inc.
71367553
In Commercial Distribution

  • 03596010403025 ()
71367553

  • Surgical mallet
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