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 HAJEK 8" 20CM
ACE SURGICAL SUPPLY CO., INC.
6400303
In Commercial Distribution

  • 00614950025022 ()

  • Length: 8 Inch
6400303

  • Surgical mallet
DRIVER HANDLE SMALL F/ACE TRUFIX & ORTHO BONE SCREWS TI
ACE SURGICAL SUPPLY CO., INC.
45419501
In Commercial Distribution

  • 00614950029198 ()
45419501

  • Screw endosteal dental implant, one-piece
REMOVAL SLEEVE FOR 1.25MM SPLINE DRIVER SS 17-4 H90
ACE SURGICAL SUPPLY CO., INC.
45417901
In Commercial Distribution

  • 00614950029129 ()
45417901

  • Screw endosteal dental implant, one-piece
MULTI-UNIT DRIVER
ACE SURGICAL SUPPLY CO., INC.
MU0028
In Commercial Distribution

  • 00614950027774 ()
MU0028

  • Dental implant suprastructure, permanent, preformed
FINAL DRIVER
Xtant Medical Holdings, Inc.
05-FINALDRIVER2
Not in Commercial Distribution

  • 00846468088453 ()
05-FINALDRIVER2

  • General internal orthopaedic fixation system implantation kit
Driver, Tapered
Pioneer Surgical Technology, Inc.
66-DRIVER-T
Not in Commercial Distribution

  • 00846468088095 ()
66-DRIVER-T

  • Surgical screwdriver, reusable
Driver, Stab And Grab
Pioneer Surgical Technology, Inc.
66-DRIVER-SG
Not in Commercial Distribution

  • 00846468088088 ()
66-DRIVER-SG

  • Surgical screwdriver, reusable
5mm Hex Simple Screw Driver(double-sided)
BAUI BIOTECH CO. LTD.
409-0815B
In Commercial Distribution

  • 04719883337429 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Hex Key#3 Driver
INTAI TECHNOLOGY CORP.
INS-DRIVER-B
In Commercial Distribution

  • 04719883200464 ()


  • Orthopaedic stereotactic surgery system
Threaded Fixation Pin Driver
INTAI TECHNOLOGY CORP.
INS-DRIVER-A
In Commercial Distribution

  • 04719883200457 ()


  • Orthopaedic stereotactic surgery system
SELF-RETAINING T15 SCREWDRIVER SHAFT
MICROWARE PRECISION CO., LTD.
303012A-K00
In Commercial Distribution

  • 04719879398045 ()


  • Surgical screwdriver, reusable
Swing Driver
Paonan Biotech Co.,Ltd.
TRN-2400
In Commercial Distribution

  • 04719878789554 ()
TRN-2400

  • Orthopaedic fixation implant alignment tool
Cannulated Screw Adjustment Driver
Paonan Biotech Co.,Ltd.
428-0800
In Commercial Distribution

  • 04719878787130 ()
428-0800

  • Orthopaedic fixation implant alignment tool
T2 Nut Driver T27
Paonan Biotech Co.,Ltd.
TR2-7001
In Commercial Distribution

  • 04719878786836 ()
TR2-7001

  • Surgical screwdriver, reusable
Screw Driver-081
INTAI TECHNOLOGY CORP.
INS-SDR081
In Commercial Distribution

  • 04719876732354 ()


  • Surgical screwdriver, reusable
TL REDUCTION SCREW INSERTER
Pioneer Surgical Technology, Inc.
02-RS-INSERTER-MDN
Not in Commercial Distribution

  • 00846468095826 ()
02-RS-INSERTER-MDN

  • Surgical screwdriver, reusable
TL SCREW INSERTER, MODULAR
Pioneer Surgical Technology, Inc.
02-SCREWINS-CL-MDN
Not in Commercial Distribution

  • 00846468095819 ()
02-SCREWINS-CL-MDN

  • Surgical screwdriver, reusable
Screw driver bit, T30
UNITED ORTHOPEDIC CORP.
9404-5105
In Commercial Distribution

  • 04719886893953 ()
9404-5105

  • Surgical screwdriver, reusable
Tibial baseplate driver
UNITED ORTHOPEDIC CORP.
9403-5101-RJ
In Commercial Distribution

  • 04719886893441 ()
9403-5101-RJ

  • Orthopaedic inorganic implant inserter/extractor, reusable
Tibial baseplate driver
UNITED ORTHOPEDIC CORP.
9403-5101-RH
In Commercial Distribution

  • 04719886893069 ()
9403-5101-RH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Torx Screw Driver T15
Paonan Biotech Co.,Ltd.
428-4330
In Commercial Distribution

  • 04719884699120 ()
428-4330

  • Surgical screwdriver, reusable
T2 Cannulated Screw Driver
Paonan Biotech Co.,Ltd.
TR2-0804C
In Commercial Distribution

  • 04719884698994 ()
TR2-0804C

  • Surgical screwdriver, reusable
5mm Hex Screw Driver(initial tightening)
BAUI BIOTECH CO. LTD.
409-0829K
In Commercial Distribution

  • 04719883858610 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Screw driver adaptor, T20
UNITED ORTHOPEDIC CORP.
9403-5331-RB
In Commercial Distribution

  • 04719886893618 ()
9403-5331-RB

  • Surgical screwdriver, reusable
Cup positioner, offset
UNITED ORTHOPEDIC CORP.
9207-1303-RA
In Commercial Distribution

  • 04719886893229 ()
9207-1303-RA

  • Orthopaedic inorganic implant inserter/extractor, reusable
Ortho mallet
UNITED ORTHOPEDIC CORP.
9304-5104-RA
In Commercial Distribution

  • 04719886891997 ()
9304-5104-RA

  • Surgical mallet
Universal screw driver
UNITED ORTHOPEDIC CORP.
9206-1114-RA
In Commercial Distribution

  • 04719886891034 ()
9206-1114-RA

  • Surgical screwdriver, reusable
Straight screw driver
UNITED ORTHOPEDIC CORP.
9206-1113-RA
In Commercial Distribution

  • 04719886891027 ()
9206-1113-RA

  • Surgical screwdriver, reusable
Cup positioner, offset
UNITED ORTHOPEDIC CORP.
9207-1303-TA
In Commercial Distribution

  • 04719886890808 ()
9207-1303-TA

  • Orthopaedic inorganic implant inserter/extractor, reusable
PRO Driver 4mm Square Drive Converter
BIOHORIZONS IMPLANT SYSTEMS, INC
PRO-4SC
In Commercial Distribution

  • 00847236026103 ()
  • 00847236026097 ()


  • Dental implant holding endpiece, reusable
Conical Implant Driver Snap Ring
BIOHORIZONS IMPLANT SYSTEMS, INC
CIDSR
In Commercial Distribution

  • 00847236024550 ()
CIDSR

  • Dental precision attachment fitting/adjustment tool
Pro Guided Implant Driver, Yellow
BIOHORIZONS IMPLANT SYSTEMS, INC
PROIDYL
In Commercial Distribution

  • 00847236022891 ()
  • 00847236023492 ()


  • Surgical screwdriver, reusable
Pro Guided Implant Driver, Purple
BIOHORIZONS IMPLANT SYSTEMS, INC
PROIDPR
In Commercial Distribution

  • 00847236022884 ()
  • 00847236023485 ()


  • Surgical screwdriver, reusable
Pro Guided Implant Driver, Grey
BIOHORIZONS IMPLANT SYSTEMS, INC
PROIDGY
In Commercial Distribution

  • 00847236022877 ()
  • 00847236023478 ()


  • Surgical screwdriver, reusable
SST TWIST DRILL, AO TYPE, 3.2mm DIA. X 120mm
Microaire Surgical Instruments LLC
8053-031NS
In Commercial Distribution

  • 00847399005250 ()

  • Outer Diameter: 3.2 Millimeter
  • Length: 120 Millimeter


  • Cannulated surgical drill bit, single-use
SST TWIST DRILL, AO TYPE, 3.2mm DIA. X 170mm
Microaire Surgical Instruments LLC
8053-029
In Commercial Distribution

  • 00847399005236 ()

  • Outer Diameter: 3.2 Millimeter
  • Length: 170 Millimeter


  • Cannulated surgical drill bit, single-use
SST TWIST DRILL, AO TYPE, 2.7mm DIA. X 75mm
Microaire Surgical Instruments LLC
8053-026NS
In Commercial Distribution

  • 00847399005212 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 75 Millimeter


  • Cannulated surgical drill bit, single-use
SST TWIST DRILL, AO TYPE, 2.7mm DIA. X 75mm
Microaire Surgical Instruments LLC
8053-026
In Commercial Distribution

  • 00847399005205 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 75 Millimeter


  • Cannulated surgical drill bit, single-use
SST TWIST DRILL, SMALL, 2.7mm Dia. x 79mm
Microaire Surgical Instruments LLC
8051-127
Not in Commercial Distribution

  • 00847399005052 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 79 Millimeter


  • Cannulated surgical drill bit, single-use
PIN DRIVER COUPLER
Microaire Surgical Instruments LLC
7505-050
In Commercial Distribution

  • 00847399004864 ()


  • Pin-driving power tool attachment
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