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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Poly Axial Screw Driver
BAUI BIOTECH CO. LTD.
409-0824
In Commercial Distribution

  • 04715862873575 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Poly Axial Screw Adjustable Driver
BAUI BIOTECH CO. LTD.
409-0813
In Commercial Distribution

  • 04715862873537 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
8mm Hex Socket Screw Driver
BAUI BIOTECH CO. LTD.
406-0808
In Commercial Distribution

  • 04715862873094 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
DRIVER EX0710385 LOCKABLE MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0710385
In Commercial Distribution

  • 00613994862464 ()


  • Orthopaedic implant driver
SCREW DRIVER EX07101280 5.5 SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX07101280
In Commercial Distribution

  • 00613994853554 ()


  • Orthopaedic implant driver
DRIVER EX0710362 3.5 CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0710362
In Commercial Distribution

  • 00613994852649 ()


  • Orthopaedic implant driver
DRIVER EX0710429 PEEK ROD MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0710429
In Commercial Distribution

  • 00613994850102 ()


  • Orthopaedic implant driver
DRIVER EX0710430 PROVISIONAL DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0710430
In Commercial Distribution

  • 00613994850096 ()


  • Orthopaedic implant driver
NUT DRIVER EX0610088 TORQUE LIMITING
MEDTRONIC SOFAMOR DANEK, INC.
EX0610088
In Commercial Distribution

  • 00613994846129 ()


  • Orthopaedic implant driver
DRIVER EX0610183 3.5MM CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0610183
In Commercial Distribution

  • 00613994839138 ()


  • Orthopaedic implant driver
Inserter Fork, Large
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK-LG
Not in Commercial Distribution

  • 00846468066505 ()


  • General internal orthopaedic fixation system implantation kit
Inserter Fork, Small
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK, SM
Not in Commercial Distribution

  • 00846468066482 ()


  • General internal orthopaedic fixation system implantation kit
Re-Entry Driver
Pioneer Surgical Technology, Inc.
86-RE-ENTRYDRV
Not in Commercial Distribution

  • 00846468064181 ()
86-RE-ENTRYDRV

  • Sternal fixation device
Inserter Shaft
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT
Not in Commercial Distribution

  • 00846468062705 ()


  • General internal orthopaedic fixation system implantation kit
Final Driver, Extended
Pioneer Surgical Technology, Inc.
21-EXTDFINALDRV-TL
Not in Commercial Distribution

  • 00846468062682 ()
21-EXTDFINALDRV-TL

  • Orthopaedic inorganic implant inserter/extractor, reusable
Angled Screw Driver Bit
Pioneer Surgical Technology, Inc.
64-ANG-SCREWDRIVER
Not in Commercial Distribution

  • 00846468081133 ()
64-ANG-SCREWDRIVER

  • General internal orthopaedic fixation system implantation kit
Screw Driver, Locking
Pioneer Surgical Technology, Inc.
64-SCREWDRIVER-LKG
Not in Commercial Distribution

  • 00846468081010 ()
64-SCREWDRIVER-LKG

  • General internal orthopaedic fixation system implantation kit
Screw Driver, Stab and Grab
Pioneer Surgical Technology, Inc.
64-SCREWDRIVER-SG
Not in Commercial Distribution

  • 00846468081003 ()
64-SCREWDRIVER-SG

  • General internal orthopaedic fixation system implantation kit
Angled Driver
Pioneer Surgical Technology, Inc.
64-ANG-DRIVER
Not in Commercial Distribution

  • 00846468080990 ()
64-ANG-DRIVER

  • General internal orthopaedic fixation system implantation kit
FINAL DRIVER
Pioneer Surgical Technology, Inc.
724-188
Not in Commercial Distribution

  • 00846468078065 ()


  • General internal orthopaedic fixation system implantation kit
Angled Screw Driver Bit
Pioneer Surgical Technology, Inc.
63-ANG-SCREWDRIVER
Not in Commercial Distribution

  • 00846468077631 ()


  • General internal orthopaedic fixation system implantation kit
Angled Driver Handle
Pioneer Surgical Technology, Inc.
63-ANG-HOUSING
Not in Commercial Distribution

  • 00846468076900 ()


  • General internal orthopaedic fixation system implantation kit
Screw Driver
Pioneer Surgical Technology, Inc.
63-SCREWDRIVER
Not in Commercial Distribution

  • 00846468076870 ()


  • General internal orthopaedic fixation system implantation kit
Angled Driver Drill Bit
Pioneer Surgical Technology, Inc.
63-ANG-DRILL
Not in Commercial Distribution

  • 00846468075040 ()


  • General internal orthopaedic fixation system implantation kit
CANNULATED HEXAGONAL DRIVER, 2.5mm
Pioneer Surgical Technology, Inc.
00-1147-062-00
In Commercial Distribution

  • 00846468074272 ()
00-1147-062-00

  • Surgical screwdriver, reusable
CANNULATED DRIVER, 5.0mm HEX
Pioneer Surgical Technology, Inc.
00-1147-049-50
In Commercial Distribution

  • 00846468074166 ()
00-1147-049-50

  • Surgical screwdriver, reusable
CANNULATED DRIVER, 3.5mm HEX
Pioneer Surgical Technology, Inc.
00-1147-049-35
In Commercial Distribution

  • 00846468074159 ()
00-1147-049-35

  • Surgical screwdriver, reusable
CANNULATED CRUCIFORM DRIVER
Pioneer Surgical Technology, Inc.
00-1147-049-00
In Commercial Distribution

  • 00846468074142 ()
00-1147-049-00

  • Surgical screwdriver, reusable
CANNULATED HEXAGONAL DRIVER, 5.0mm TRINKILE
Pioneer Surgical Technology, Inc.
00-1147-048-00
In Commercial Distribution

  • 00846468074135 ()
00-1147-048-00

  • Screwing power tool attachment
CANNULATED HEXAGONAL DRIVER, 3.5mm TRINKLE
Pioneer Surgical Technology, Inc.
00-1147-047-00
In Commercial Distribution

  • 00846468074128 ()
00-1147-047-00

  • Screwing power tool attachment
Q/C CANNULATED HEXAGONAL DRIVER, 2.5mm
Pioneer Surgical Technology, Inc.
00-1147-046-00
In Commercial Distribution

  • 00846468074111 ()
00-1147-046-00

  • Screwing power tool attachment
Q/C CANNULATED CRUCIFORM DRIVER
Pioneer Surgical Technology, Inc.
00-1147-045-00
In Commercial Distribution

  • 00846468074081 ()
00-1147-045-00

  • Screwing power tool attachment
3mm Hex Screw Driver
BAUI BIOTECH CO. LTD.
406-0830A
In Commercial Distribution

  • 04718005155231 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9906.0014.11S
In Commercial Distribution

  • 04717002404335 ()
  • 14717002404332 ()
  • 24717002404339 ()
9906.0014.11S

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mono Axial Screw Driver
BAUI BIOTECH CO. LTD.
409-0823
In Commercial Distribution

  • 04715862873568 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Impactor head
UNITED ORTHOPEDIC CORP.
9303-5711
In Commercial Distribution

  • 04719872145721 ()
9303-5711

  • Orthopaedic inorganic implant inserter/extractor, reusable
Femoral driver
UNITED ORTHOPEDIC CORP.
9303-5710
In Commercial Distribution

  • 04719872145714 ()
9303-5710

  • Orthopaedic inorganic implant inserter/extractor, reusable
Cup positioner, offset
UNITED ORTHOPEDIC CORP.
9207-1303
In Commercial Distribution

  • 04719872143246 ()
9207-1303

  • Orthopaedic inorganic implant inserter/extractor, reusable
Cup positioner, straight
UNITED ORTHOPEDIC CORP.
9207-1103
In Commercial Distribution

  • 04719872143239 ()
9207-1103

  • Orthopaedic inorganic implant inserter/extractor, reusable
Set screw driver adaptor, T8
UNITED ORTHOPEDIC CORP.
9315-5101-RC
In Commercial Distribution

  • 04719872143222 ()
9315-5101-RC

  • Orthopaedic implant-instrument extension adaptor, reusable
Sliding hammer
UNITED ORTHOPEDIC CORP.
9303-5311-TB
In Commercial Distribution

  • 04719872142867 ()
9303-5311-TB

  • Surgical mallet
Universal screw driver, T20
UNITED ORTHOPEDIC CORP.
9208-1103
In Commercial Distribution

  • 04719872142591 ()
9208-1103

  • Surgical screwdriver, reusable
Screw driver, T20
UNITED ORTHOPEDIC CORP.
9208-1102
In Commercial Distribution

  • 04719872142584 ()
9208-1102

  • Surgical screwdriver, reusable
Cup impactor driver
UNITED ORTHOPEDIC CORP.
9206-1118
In Commercial Distribution

  • 04719872141525 ()


  • Surgical screwdriver, reusable
Driver handle, 3/8" SQ
UNITED ORTHOPEDIC CORP.
9415-1302
In Commercial Distribution

  • 04719872140177 ()


  • Surgical instrument handle, non-torque-limiting
USTAR II Stem trial driver
UNITED ORTHOPEDIC CORP.
9315-1102
In Commercial Distribution

  • 04719872140160 ()


  • Surgical instrument handle, non-torque-limiting
A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.
ENTER MEDICAL CORPORATION
PN-2002
In Commercial Distribution

  • 04719872108795 ()


  • Mouth gag, non-adjustable
PIN DRIVER
Pioneer Surgical Technology, Inc.
27-PIN-DRIVER
Not in Commercial Distribution

  • 00846468051631 ()


  • General internal orthopaedic fixation system implantation kit
HEXALOBE SET SCREW DRIVER SHAFT
ALPHATEC SPINE, INC.
92939
In Commercial Distribution

  • 00844856044357 ()


  • Surgical screwdriver, reusable
MALLET
ALPHATEC SPINE, INC.
73702
In Commercial Distribution

  • 00844856043923 ()


  • Surgical mallet
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