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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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Novo Surgical - G586OP7125470

dix needle & gouge, in reversible screw handle, gouge only
NOVO SURGICAL, INC.
OP7125-47
In Commercial Distribution

  • G586OP7125470 ()
OP7125-47

  • Eye spud

Novo Surgical - G586OP7125460

dix needle & gouge, in reversible screw handle, needle only
NOVO SURGICAL, INC.
OP7125-46
In Commercial Distribution

  • G586OP7125460 ()
OP7125-46

  • Eye spud

Novo Surgical - G586OP7125450

dix needle & gouge, in reversible screw handle, complete set
NOVO SURGICAL, INC.
OP7125-45
In Commercial Distribution

  • G586OP7125450 ()
OP7125-45

  • Eye spud

EVOLUTION - 00192629276826

EVOLUTION HINGE 4 IN 1 3 DEG VALGUS BUSHING
Microport Orthopedics Inc.
E1200313
In Commercial Distribution

  • M684E12003131 ()
  • 00192629276826 ()
E1200313

  • Joint prosthesis implantation kit, reusable

EVOLUTION® - 00192629271555

EVOLUTION® REAMER / ROD 13 IN W/ QUICK DISCONNECT
Microport Orthopedics Inc.
E5001003CN
In Commercial Distribution

  • M684E5001003CN1 ()
  • 00192629271555 ()
E5001003CN

  • Bone-resection orthopaedic reamer, reusable

EVOLUTION - 00192629247987

EVOLUTION REV OPT 4 IN 1 RSCT SIZE 2
Microport Orthopedics Inc.
E1204512
In Commercial Distribution

  • M684E12045121 ()
  • 00192629247987 ()
E1204512

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Valeo Spacer System - M555910000022

Valeo TL/PL Disc Prep, 4 in Aesculap Container
AMEDICA CORPORATION
C
Not in Commercial Distribution

  • M555910000022 ()
91.000.0022

  • Instrument tray, reusable

X-Mark - B88710080

1.15mm x 2cm X-MARK Preloaded in 17 g Needle
Izi Medical Products, LLC
1008
In Commercial Distribution

  • B88710080 ()
1008

  • Radiological image marker, implantable

X-MARK Ultra - B8870010780

0.85mm x 2cm X-MARK Ultra Preloaded in 18g Needle
Izi Medical Products, LLC
001078
In Commercial Distribution

  • B8870010780 ()
001078

  • Radiological image marker, implantable

X-MARK Ultra - B8870010680

1.15mm x 2cm X-MARK Ultra Preloaded in 17g needle
Izi Medical Products, LLC
001068
In Commercial Distribution

  • B8870010680 ()
001068

  • Radiological image marker, implantable
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