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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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EVOLUTION® CS / CR FEM HOLDER/ DRIVER
Microport Orthopedics Inc.
E1005103CN
In Commercial Distribution

  • M684E1005103CN1 ()
  • 00192629271944 ()
E1005103CN

  • Surgical implant/trial-implant/sizer holder, reusable
EVOLUTION® HEX / PIN DRIVER
Microport Orthopedics Inc.
E5001004CN
In Commercial Distribution

  • M684E5001004CN1 ()
  • 00192629271760 ()
E5001004CN

  • Surgical screwdriver, reusable
EVOLUTION® 3.5MM HEX DRIVER
Microport Orthopedics Inc.
E5001005CN
In Commercial Distribution

  • M684E5001005CN1 ()
  • 00192629271579 ()
E5001005CN

  • Surgical screwdriver, reusable
HEX DRIVER SHAFT W/STRYKR STRAIGHT SOLID 3.5MM
Microport Orthopedics Inc.
8400SD06
In Commercial Distribution

8400SD06

  • Joint prosthesis implantation kit, reusable
A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE. THIS CUP IS SOLD SINGLY TO ACCOMMODATE HOSPITALS WHO WISH TO BUY IN BULK. HOWEVER TWO CUPS ARE REQUIRED TO BE ATTACHED TO THE PLATFORM WHEN IT IS BEING USED.
JB Medical Development, LLC
14-101-01
In Commercial Distribution

  • B99214101010 ()
1410101

  • Surgical instrument interim-placement holder, single-use
#8 Torx Driver
Leith Medical LLC
9001-0008
In Commercial Distribution

  • B953900100080 ()

  • Length: 3.5 Inch


  • Orthopaedic implant driver
Carbon Fiber Handle
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF10060 ()
NF-1006

  • External spinal fixation system
Facet Sound
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF10040 ()
NF-1004

  • External spinal fixation system
Stainless Steel Facet Locator - Cannulated
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF1001SC0 ()
NF-1001SC

  • External spinal fixation system
Stainless Steel Facet Locator
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF1001S0 ()
NF-1001S

  • External spinal fixation system
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