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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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K2M General Instruments - 10888857468931

Silicone T-Handle with Strike Plate Black
K2M, INC.
3201-90274
In Commercial Distribution

  • 10888857468931 ()
3201-90274

  • Orthopaedic prosthesis implantation positioning instrument, reusable

N/A - 00643169671256

DISTRACTOR X0615033 LRGE WITH HNGE BLACK
MEDTRONIC SOFAMOR DANEK, INC.
X0615033
In Commercial Distribution

  • 00643169671256 ()


  • Orthopaedic surgical distractor, internal

N/A - 00643169671249

DISTRACTOR X0615032 SMLL WITH HNGE BLACK
MEDTRONIC SOFAMOR DANEK, INC.
X0615032
In Commercial Distribution

  • 00643169671249 ()


  • Orthopaedic surgical distractor, internal

N/A - 00643169392359

MARKER X0713177 PEDICLE CONICAL WITH CYL
MEDTRONIC SOFAMOR DANEK, INC.
X0713177
In Commercial Distribution

  • 00643169392359 ()


  • General internal orthopaedic fixation system implantation kit

VIKOS Allograft System - 10888857152243

Impactor, with Stop Size 11.5x14.5 mm
K2M, INC.
2504-90015
In Commercial Distribution

  • 10888857152243 ()
2504-90015

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Resuable Instruments - 00643169692121

RASP EX0915004 CURVED WITH REVERSE ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0915004
In Commercial Distribution

  • 00643169692121 ()


  • Bone file/rasp, manual, reusable

Medtronic Reusable Instruments - 00643169080416

FOOTED TAMP EX0611252 WITH LATERAL GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
EX0611252
In Commercial Distribution

  • 00643169080416 ()


  • Surgical tamp, reusable

Mastel Precision Surgical Instruments, Inc. - 00642356200705

OZM Marker With Cross Hairs - 9.00mmThornton
Mastel Precision Surgical Instruments, Inc.
20.111.0902
In Commercial Distribution

  • 00642356200705 ()
20.111.0902

  • Corneal marker, reusable

Speedlock - 00848657072595

Speedlock Babcock, 10mm, 45cm, with ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8514-57-45-R
In Commercial Distribution

  • 00848657072595 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Micro Precise - 00848657066952

Croc Grasping Forcep with Ratchet 2.8mm
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
xs1303-R
In Commercial Distribution

  • 00848657066952 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
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