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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3 1/2' BLADE LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-524L
In Commercial Distribution

  • 00673978130545 ()


  • Bone trephine, reusable
2 1/2' WIDE BLADE RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-523R
In Commercial Distribution

  • 00673978130538 ()


  • Bone trephine, reusable
2 1/2' WIDE BLADE LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-523L
In Commercial Distribution

  • 00673978130521 ()


  • Bone trephine, reusable
2 1/2' BLADE RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-522R
In Commercial Distribution

  • 00673978130514 ()


  • Bone trephine, reusable
2 1/2' BLADE LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-522L
In Commercial Distribution

  • 00673978130507 ()


  • Bone trephine, reusable
1 1/2' WIDE BLADE RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-521R
In Commercial Distribution

  • 00673978130491 ()


  • Bone trephine, reusable
1 1/2' WIDE BLADE LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-521L
In Commercial Distribution

  • 00673978130484 ()


  • Bone trephine, reusable
1 1/2' BLADE RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-520R
In Commercial Distribution

  • 00673978130477 ()


  • Bone trephine, reusable
1 1/2' BLADE LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0196-520L
In Commercial Distribution

  • 00673978130460 ()


  • Bone trephine, reusable
KNURLED NUTS X0196-501
MEDTRONIC SOFAMOR DANEK, INC.
X0196-501
In Commercial Distribution

  • 00673978130453 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REAMER X0196-124 CANNULATED TAPERED
MEDTRONIC SOFAMOR DANEK, INC.
X0196-124
In Commercial Distribution

  • 00673978130439 ()


  • Orthopaedic broach
SIZE 2 CURETTE (EPSTEIN)
MEDTRONIC SOFAMOR DANEK, INC.
X0196-051
In Commercial Distribution

  • 00673978130279 ()


  • Bone curette, reusable
SIZE 4 CURETTE (EPSTEIN)
MEDTRONIC SOFAMOR DANEK, INC.
X0196-050
In Commercial Distribution

  • 00673978130262 ()


  • Bone curette, reusable
SIZE 0 CURETTE (EPSTEIN)
MEDTRONIC SOFAMOR DANEK, INC.
X0196-049
In Commercial Distribution

  • 00673978130255 ()


  • Bone curette, reusable
STRAIGHT 50MM PROBE
MEDTRONIC SOFAMOR DANEK, INC.
X0196-047
In Commercial Distribution

  • 00673978130231 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
DRILL GUIDE/FOR TAPERED DRILL
MEDTRONIC SOFAMOR DANEK, INC.
X0196-046
In Commercial Distribution

  • 00673978130224 ()


  • Surgical drill guide, reusable
10MM CURVED OSTEOTOME
MEDTRONIC SOFAMOR DANEK, INC.
X0196-042
In Commercial Distribution

  • 00673978130200 ()


  • Orthopaedic osteotome
5MM CURVED OSTEOTOME
MEDTRONIC SOFAMOR DANEK, INC.
X0196-041
In Commercial Distribution

  • 00673978130194 ()


  • Orthopaedic osteotome
5MM X 10MM BONE TAMP
MEDTRONIC SOFAMOR DANEK, INC.
X0196-040
In Commercial Distribution

  • 00673978130187 ()


  • Surgical tamp, reusable
5.0 CAPTIVE TWIST HEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0196-039
In Commercial Distribution

  • 00673978130170 ()


  • Orthopaedic implant driver
T-HANDLE CAP TWST MUNIP 3.5HEX
MEDTRONIC SOFAMOR DANEK, INC.
X0196-029
In Commercial Distribution

  • 00673978130125 ()


  • Orthopaedic implant driver
6.5MM SOLID TAP W/MODIFIED TIP
MEDTRONIC SOFAMOR DANEK, INC.
X0196-000
In Commercial Distribution

  • 00673978129976 ()


  • Bone tap, reusable
PROBE TIP
MEDTRONIC SOFAMOR DANEK, INC.
X0195-165
In Commercial Distribution

  • 00673978129839 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0195-154
In Commercial Distribution

  • 00673978129778 ()


  • Surgical instrument handle, non-torque-limiting
ORION PLATE HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
X0195-005
In Commercial Distribution

  • 00673978129532 ()


  • Surgical implant/trial-implant/sizer holder, reusable
TAP X0194-027 TRPD 4.5MM-7.5MM DIA L20MM
MEDTRONIC SOFAMOR DANEK, INC.
X0194-027
In Commercial Distribution

  • 00673978129501 ()


  • Bone tap, reusable
TAP X0194-026 SLD TPRD 4.5MM-6.5MM DIA
MEDTRONIC SOFAMOR DANEK, INC.
X0194-026
In Commercial Distribution

  • 00673978129495 ()


  • Bone tap, reusable
RATCHETING CORKSCREW
MEDTRONIC SOFAMOR DANEK, INC.
X0194-024
In Commercial Distribution

  • 00673978129471 ()


  • Orthopaedic bone screw starter/notcher
INSTRUMENT HD6107 CDH DRAWER REMOVER
MEDTRONIC SOFAMOR DANEK, INC.
HD6107
In Commercial Distribution

  • 00673978121772 ()


  • Orthopaedic implantation sleeve, reusable
ROD C6907 RIGHT MARKER
MEDTRONIC SOFAMOR DANEK, INC.
C6907
In Commercial Distribution

  • 00673978111070 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
ROD C6906 LEFT MARKER
MEDTRONIC SOFAMOR DANEK, INC.
C6906
In Commercial Distribution

  • 00673978111063 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE C6905 STIFF FEELER
MEDTRONIC SOFAMOR DANEK, INC.
C6905
In Commercial Distribution

  • 00673978111056 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
M8 INST C6880 FINAL PLUG DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
C6880
In Commercial Distribution

  • 00673978110998 ()


  • Orthopaedic implant driver
M8 INSTRUMENT C6841 TORX 20 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
C6841
In Commercial Distribution

  • 00673978110936 ()


  • Orthopaedic implant driver
INSTRUMENT C6202 CCD ROD HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
C6202
In Commercial Distribution

  • 00673978110547 ()


  • Orthopaedic fixation implant alignment tool
KERRISON 9560581 UPBITING 2MM 90
MEDTRONIC SOFAMOR DANEK, INC.
9560581
In Commercial Distribution

  • 00673978086354 ()


  • Bone curette, reusable
UPBITING 9560580 KERRISON 2MM 40
MEDTRONIC SOFAMOR DANEK, INC.
9560580
In Commercial Distribution

  • 00673978086347 ()


  • Bone curette, reusable
INSTRUMENT 9560570 4MM UPBITING PIT
MEDTRONIC SOFAMOR DANEK, INC.
9560570
In Commercial Distribution

  • 00673978086316 ()


  • Orthopaedic joint/limb rongeur
INSTRUMENT 9560569 2MM DOWNBIT PITUITARY
MEDTRONIC SOFAMOR DANEK, INC.
9560569
In Commercial Distribution

  • 00673978086286 ()


  • Orthopaedic joint/limb rongeur
INSTRUMENT 9560566 2MM PITUITARY W/TOOTH
MEDTRONIC SOFAMOR DANEK, INC.
9560566
In Commercial Distribution

  • 00673978086194 ()


  • Orthopaedic joint/limb rongeur
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