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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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(C3.4) Ø3.5/ L10.0
Megagen Implant Co. Ltd
EF3510
In Commercial Distribution

  • 08806388213061 ()
EF3510P

  • Screw endosteal dental implant, two-piece
(C3.4) Ø3.5/ L8.5
Megagen Implant Co. Ltd
EF3508
In Commercial Distribution

  • 08806388213047 ()
EF3508P

  • Screw endosteal dental implant, two-piece
(C3.4) Ø3.5/ L7.0
Megagen Implant Co. Ltd
EF3507
In Commercial Distribution

  • 08806388213023 ()
EF3507P

  • Screw endosteal dental implant, two-piece
No Description
ICECURE MEDICAL LTD
CSS-2004055
In Commercial Distribution

  • 07290015487528 ()

  • Depth: 736 Millimeter
  • Height: 1184 Millimeter
  • Width: 480 Millimeter


  • General cryosurgical system, cryogen gas, electronic
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. 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
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
XCALIBER MANIPULATION FORCEPS
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568035216 ()
19200

  • External orthopaedic fixation system, reusable
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
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
UE XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169719 ()
99-91647UE

  • External orthopaedic fixation system, single-use
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 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
SUPPLEMENTARY SCREW HOLDER (BARS AND CLAMPS) STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863338 ()
99-91038

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

  • 18032568863321 ()
99-91015

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

  • 18032568863307 ()
99-91000

  • External orthopaedic fixation system, single-use
RADIOLUCENT ANKLE PIN GUIDE STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861617 ()
99-11947

  • External orthopaedic fixation system, single-use
CANNULATED DRILL BIT WITH WIRE D 3.2 MM LENGTH 150 MM STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861600 ()

  • Length: 150 Millimeter
  • Outer Diameter: 3.2 Millimeter
99-11013

  • Fluted surgical drill bit, single-use
SUPPLEMENTARY SCREW HOLDER BAR RADIOLUCENT 150 MM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568861358 ()

  • Width: 7 Millimeter
91039

  • External orthopaedic fixation system, reusable
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