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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2MM DISTRACTION SHIMS
Smith & Nephew, Inc.
71061002
In Commercial Distribution

  • 23596010475743 ()
  • 03596010475749 ()
71061002

  • External orthopaedic fixation system, single-use
CENTRAL PIN FIXATION UNIT
Smith & Nephew, Inc.
71050008
In Commercial Distribution

  • 03596010454454 ()
71050008

  • External orthopaedic fixation system, reusable
HEIDELBERG STANDARD CENTRAL BODY
Smith & Nephew, Inc.
71050002
In Commercial Distribution

  • 03596010454447 ()
71050002

  • External orthopaedic fixation system, reusable
ILIZ./HEXFIX KOMBISCHL?SSEL
Smith & Nephew, Inc.
76522009
In Commercial Distribution

  • 03596010441584 ()
76522009

  • External orthopaedic fixation system, reusable
HEX-FIX 5mm PIN CENTERING SLEEVE
Smith & Nephew, Inc.
71031033
In Commercial Distribution

  • 03596010439901 ()
71031033

  • Orthopaedic implantation sleeve, reusable
PIN TOWER
Smith & Nephew, Inc.
71050009
In Commercial Distribution

  • 03596010439833 ()
71050009

  • External orthopaedic fixation system, reusable
HEIDELBERG ANGULATOR
Smith & Nephew, Inc.
71050006
In Commercial Distribution

  • 03596010439819 ()
71050006

  • External orthopaedic fixation system, reusable
HEX-FIX 6mm PIN CENTERING SLEEVE
Smith & Nephew, Inc.
71031034
In Commercial Distribution

  • 03596010436313 ()
71031034

  • Orthopaedic implantation sleeve, reusable
DRS STRAIGHT ROD 150MM
Smith & Nephew, Inc.
71033004
In Commercial Distribution

  • 03596010432339 ()
71033004

  • External orthopaedic fixation system, reusable
STRAIGHT ROD 75MM
Smith & Nephew, Inc.
71033003
In Commercial Distribution

  • 03596010432322 ()
71033003

  • External orthopaedic fixation system, reusable
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale. A Ventricular Catheter Accessory Kit (VCAK). A Pressure Transducer.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910123A
Not in Commercial Distribution

  • 10381780035589 ()
  • M272910123A1 ()

  • Cylinder 75ml, Drainage Bag 500ml, Vent. Cath. 35cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducers 22cm and 37cm Length
910123A

  • Ventricular cerebrospinal fluid drainage catheterization kit
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale. A Lumbar Catheter Accessory Kit (LCAK).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910120A
Not in Commercial Distribution

  • 10381780035565 ()
  • M272910120A1 ()

  • Cylinder 75ml, Drainage Bag 500ml , Lumbar Cath. 80cm Length x 1.6mm O.D. x 0.8mm I.D. (F5), 14G Tuohy Needle
910120A

  • Lumbar cerebrospinal fluid drainage catheterization kit
6 Drainable Collection Bags, 500 ml, with female Luer-lock connector, a suspension hook, and a hydrophobic filter.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910116D
Not in Commercial Distribution

  • 30381780035552 ()
  • 10381780035558 ()
  • M272910116D1 ()

  • Drainage Bag 500ml, Hydrophobic Filter 0.45µm
910116D

  • Cerebrospinal fluid external drainage kit
Replacement Drainage Bag, 500 ml, with female Luer-lock connector, a suspension hook, and a hydrophobic filter.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910116A
Not in Commercial Distribution

  • 30381780035545 ()
  • 10381780035541 ()
  • M272910116A1 ()

  • Drainage Bag 500ml, Hydrophobic Filter 0.45µm
910116A

  • Cerebrospinal fluid external drainage kit
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale. It also includes a Ventricular Catheter Accessory Kit.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910112A
Not in Commercial Distribution

  • 10381780035527 ()
  • M272910112A1 ()

  • Cylinder 75ml, Drainage Bag 500ml, Vent. Cath. 35cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducers 22cm and 37cm Length
910112A

  • Ventricular cerebrospinal fluid drainage catheterization kit
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910109
Not in Commercial Distribution

  • M2729101091 ()
  • 10381780034117 ()

  • Cylinder 75ml, Drainage Bag 500ml


  • Cerebrospinal fluid external drainage kit
PRECICE ERC 4P Shipping Pkg US
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC 4P
In Commercial Distribution

  • 00887517014979 ()

  • Tool/Instrument
EAD-P4-010

  • Distraction implant adjustment remote control
UE XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169719 ()
99-91647UE

  • External orthopaedic fixation system, single-use
JP XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169702 ()
99-91647JP

  • External orthopaedic fixation system, single-use, sterile
UE XCALIBER METADIAPHYSEAL COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169696 ()
99-91600UE

  • External orthopaedic fixation system, single-use
JP XCALIBER METADIAPHYSEAL COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169689 ()
99-91600JP

  • External orthopaedic fixation system, single-use, sterile
US XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937167791 ()
99-91647

  • External orthopaedic fixation system, single-use
US XCALIBER METADIAPHYSEAL COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937167784 ()
99-91600

  • External orthopaedic fixation system, single-use
XCALIBER/PROCALLUS HYBRID INSTRUMENTS STERIBOX, EMPTY
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867299 ()
91980

  • Instrument tray, reusable
XCALIBER META-DIAPHYSEAL/ANKLE INSTRUMENTS STERIBOX, EMPTY
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867282 ()
91990

  • Instrument tray, reusable
XCALIBER ARTICULATED ANKLE KIT WITH DYNAMIC C/D UNIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867213 ()
99-91245

  • External orthopaedic fixation system, single-use
XCALIBER META-DIAPHYSEAL KIT WITH DYNAMIC C/D UNIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568867206 ()
99-91215

  • External orthopaedic fixation system, single-use
XCALIBER MANIPULATION FORCEPS
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568035216 ()
19200

  • External orthopaedic fixation system, reusable
RAIL DISTRACTOR LOW PROFILE RIGHT
Smith & Nephew, Inc.
71934149
Not in Commercial Distribution

  • 00885556534038 ()
71934149

  • External orthopaedic fixation system, single-use
1 HOLE 3 DEGREE RANCHO CUBE
Smith & Nephew, Inc.
71932452
In Commercial Distribution

  • 00885556057414 ()
71932452

  • External orthopaedic fixation system, single-use
FOCAL DOME OSTEOTOMY GUIDE ASSEMBLY
Smith & Nephew, Inc.
71929621
In Commercial Distribution

  • 00885556049839 ()
71929621

  • Orthopaedic osteotome
4 HOLE CUBE W/THREADED END
Smith & Nephew, Inc.
71929495
In Commercial Distribution

  • 00885556048719 ()
71929495

  • External orthopaedic fixation system, reusable
17 DEGREE WEDGE
Smith & Nephew, Inc.
71929494
Not in Commercial Distribution

  • 00885556048573 ()
71929494

  • External orthopaedic fixation system, reusable
TRACTION PIN W/TROCAR POINT BOTH ENDS 5/64X9.0
Smith & Nephew, Inc.
71927392
Not in Commercial Distribution

  • 00885556045602 ()
71927392

  • External orthopaedic fixation system, single-use
HEX FIX SWIVEL ADAPTER
Smith & Nephew, Inc.
71925829
Not in Commercial Distribution

  • 00885556045015 ()
71925829

  • General internal orthopaedic fixation system implantation kit
No Description
CAPTIVA SPINE, INC.
2231-7009
In Commercial Distribution

  • M739223170090 ()


  • Orthopaedic rod reducer
INSTRUMENT CASE
Smith & Nephew, Inc.
71061010
In Commercial Distribution

  • 00885556119686 ()
71061010

  • Instrument tray, reusable
PRECICE ERC 3P Shipping Pkg US
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERC 3P
In Commercial Distribution

  • 00887517001344 ()

  • Tool/Instrument
EAD-P3-010

  • Distraction implant adjustment remote control
XCALIBER HYBRID KIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863352 ()
99-91080

  • External orthopaedic fixation system, single-use
XCALIBER ARTICULATED ANKLE KIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863345 ()
99-91047

  • External orthopaedic fixation system, single-use
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