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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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ARTICULATED SHAFT SMALL AO TO MODIFIED T27 TORX TIP
GAUTHIER BIOMEDICAL, INC.
GC101211
In Commercial Distribution

  • 00858325005756 ()
GC101211

  • Surgical screwdriver, reusable
ROD PUSHER 5.5/6.0
GAUTHIER BIOMEDICAL, INC.
5161-00-5030 (GC101061)
In Commercial Distribution

  • 00858325005664 ()
5161005030

  • Orthopaedic implant driver
Shaft, 1 / 4 inch (6,35mm) Square to 4mm Hex
GAUTHIER BIOMEDICAL, INC.
GC100185
In Commercial Distribution

  • 00858325005268 ()
GC100185

  • Surgical screwdriver, reusable
Shaft, 1 / 4 inch (6,35mm) Square to 5mm Hex
GAUTHIER BIOMEDICAL, INC.
GC100184
In Commercial Distribution

  • 00858325005251 ()
GC100184

  • Surgical screwdriver, reusable
This hand - held, orthopedic, manual, surgical instrument handle is designed to connect to shaft type instruments, such as awls, taps, screw drivers and similar instruments used by a surgeon to prepare fasteners or constructs for installation, driving or adjusting fasteners or to perform manipulations during surgery. This is a reusable device.
GAUTHIER BIOMEDICAL, INC.
G107212
In Commercial Distribution

  • 00858325005060 ()
G107212

  • Surgical instrument handle, non-torque-limiting
Articulated Shaft Small AO T27 Torx tip
GAUTHIER BIOMEDICAL, INC.
GC101210
In Commercial Distribution

  • 00858325005053 ()
GC101210

  • Surgical screwdriver, reusable
Ziptek large stainless steel driver/handle assembly reusable medical grade stainless steel ofr use with large 5.0mm screws and biocomposite plugs and as ZipE capture/button pusher
ZIPTEK LLC
B56-793-S_D
In Commercial Distribution

  • 00858816006101 ()
01

  • Surgical instrument handle, non-torque-limiting
Ziptek small driver/handle assembly medical grade stainless steel for 4.5mm screw insertion and for pushing capture/button
ZIPTEK LLC
B56-635-S_D
In Commercial Distribution

  • 00858816006088 ()
88

  • Surgical instrument handle, non-torque-limiting
ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
A6-6545-S
In Commercial Distribution

  • 00858816006033 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices 5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
A6-6550-S
In Commercial Distribution

  • 00858816006026 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
RA6-6565-S
In Commercial Distribution

  • 00858816006019 ()


  • Tendon/ligament bone anchor, bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S 5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver
ZIPTEK LLC
RA6-6550-S
In Commercial Distribution

  • 00858816006002 ()


  • Tendon/ligament bone anchor, bioabsorbable
Pin Driver, Tri-flat, Hudson Connector
Orthalign, Inc.
403162
In Commercial Distribution

  • 00858704006954 ()
403162

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Ball Hex Driver 6mm, Teardrop
Orthalign, Inc.
403211
In Commercial Distribution

  • 00858704006756 ()
403211

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Pin Driver, Tri-Flat, 3.2mm
Orthalign, Inc.
403189
In Commercial Distribution

  • 00858704006435 ()
403189

  • Orthopaedic surgical procedure kit, non-medicated, reusable
2.5mm Ball Driver
Orthalign, Inc.
402048
In Commercial Distribution

  • 00858704006374 ()
402048

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Hex Driver - 3.5mm, Hudson Connector
Orthalign, Inc.
403106
In Commercial Distribution

  • 00858704006619 ()
403106

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Hex Driver - 3.5mm, Teardrop
Orthalign, Inc.
403105
In Commercial Distribution

  • 00858704006602 ()
403105

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Pin Driver
Orthalign, Inc.
402067
In Commercial Distribution

  • 00858704006428 ()
402067

  • Orthopaedic surgical procedure kit, non-medicated, reusable
PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO.
PONTIS ORTHOPAEDICS, LLC
400-3031
In Commercial Distribution

  • 00859210006025 ()

  • Length: 4.5 Millimeter
  • Outer Diameter: 3 Millimeter
400-3031

  • Tendon/ligament bone anchor, non-bioabsorbable
AXIS/ORION SCREWDRIVER SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X1196-002
In Commercial Distribution

  • 00673978153773 ()


  • Orthopaedic implant driver
DYNA-LOK RIGID BOLT DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0598-005
In Commercial Distribution

  • 00673978141251 ()


  • Orthopaedic implant driver
HEX SCREWDRIVER X0399-002 7/32 INCH
MEDTRONIC SOFAMOR DANEK, INC.
X0399-002
In Commercial Distribution

  • 00673978135939 ()


  • Orthopaedic implant driver
MA SCREWDRIVER SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0397-003
In Commercial Distribution

  • 00673978135496 ()


  • Orthopaedic implant driver
AXIS SCREWDRIVER X0295-023 11 INCH LONG
MEDTRONIC SOFAMOR DANEK, INC.
X0295-023
In Commercial Distribution

  • 00673978132280 ()


  • Orthopaedic implant driver
T-HANDLE EXT LENGTH HEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0199-038
In Commercial Distribution

  • 00673978131788 ()


  • Orthopaedic implant driver
CDH T-HANDLE T20 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0199-016
In Commercial Distribution

  • 00673978131566 ()


  • Orthopaedic implant driver
CDH T-HANDLE PROV PLUG DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0199-015
In Commercial Distribution

  • 00673978131559 ()


  • Orthopaedic implant driver
RASP SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0198-005
In Commercial Distribution

  • 00673978131108 ()


  • Orthopaedic implant driver
5.0 CAPTIVE TWIST HEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0196-039
In Commercial Distribution

  • 00673978130170 ()


  • Orthopaedic implant driver
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