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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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RABEA 0° - 04047844000243

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000243 ()

  • 5x12x16mm
P051216

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000236

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000236 ()

  • 5x12x12mm
P051212

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000229

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000229 ()

  • 4x12x16mm
P041216

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000212

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000212 ()

  • 4x12x12mm
P041212

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000205

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000205 ()

  • 3x12x12mm
P031212

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000052

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000052 ()

  • 7x12x14mm
P071214

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000045

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000045 ()

  • 6x12x14mm
P061214

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000038

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000038 ()

  • 5x12x14mm
P051214

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000021

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000021 ()

  • 4x12x14mm
P041214

  • Metallic spinal interbody fusion cage

RABEA 0° - 04047844000014

The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000014 ()

  • 3x12x14mm
P031214

  • Metallic spinal interbody fusion cage

Contra Angle 70:1 - ENOU5065NOU0

Contra Angle 70:1
Nouvag AG
5065NOU
In Commercial Distribution

  • ENOU5065NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 16:1 Endodontics - ENOU5061NOU0

Contra Angle 16:1 Endodontics
Nouvag AG
5061NOU
In Commercial Distribution

  • ENOU5061NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 8:1 Endodontics - ENOU5057NOU0

Contra Angle 8:1 Endodontics
Nouvag AG
5057NOU
In Commercial Distribution

  • ENOU5057NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 32:1 - ENOU5054NOU0

Contra Angle 32:1
Nouvag AG
5054NOU
In Commercial Distribution

  • ENOU5054NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 20:1 LED - ENOU5052NOU0

Contra Angle 20:1 LED
Nouvag AG
5052nou
In Commercial Distribution

  • ENOU5052NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 1:1 - ENOU5051NOU0

Contra Angle 1:1
Nouvag AG
5051NOU
In Commercial Distribution

  • ENOU5051NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Contra Angle 1:1 - ENOU5050NOU0

Contra Angle 1:1
Nouvag AG
5050NOU
In Commercial Distribution

  • ENOU5050NOU0 ()


  • Line-powered dental drilling/sawing system handpiece

Clip for Contra Angle - ENOU18819

Clip for Contra Angle
Nouvag AG
1881
In Commercial Distribution

  • ENOU18819 ()
  • ENOU18810 ()


  • Line-powered dental drilling/sawing system handpiece

Hu-Friedy - 10889950002732

IMS STERILIZATION WRAP 24 x 24 100 SHEET
HU-FRIEDY MFG. CO., LLC
IMS-1210H
In Commercial Distribution

  • 10889950002732 ()
  • 10889950075033 ()
IMS-1210H

  • Sterilization packaging, single-use

Encompass - 00609953925981

24 X 24 2 PLY DRAPE T180 MIST
Encompass Group, L.L.C.
CD0033
In Commercial Distribution

  • 50609953925986 ()
  • 00609953925981 ()


  • Patient surgical drape, reusable

Coulmed - 10810087350106

Covex Sterile X-Ray Cassette Cover: 24" x 24"
Coulmed Products Group LLC
DI-5503
In Commercial Distribution

  • 30810087350100 ()
  • 10810087350106 ()
DI-5503

  • Medical equipment/instrument drape, single-use

Perma Pure - 00840106901784

24" DRYER, MED. GRAPHICS 24" DRYER, MED. GRAPHICS
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 00840106901821 ()
  • 00840106901784 ()
  • 00840106901814 ()
  • 00840106901807 ()
  • 00840106901791 ()
ME-050-03-99

  • Gas-sampling/monitoring respiratory tubing, single-use

Tissue-Tek® - 00615233078100

Base Mold 24 x 24 x 5 mm
SAKURA FINETEK U.S.A., INC.
4163
In Commercial Distribution

  • 00615233078100 ()
4163

  • Tissue embedding mould IVD, reusable

OPTICS ONE - 00815384022346

X-ray Cassette Cover 24 x 24 Adhesive Closure
MEDICAL TECHNIQUE, INC.
9954-50
In Commercial Distribution

  • 00815384022360 ()
  • 00815384022353 ()
  • 00815384022346 ()
9954-50

  • Instrument/equipment drape, single-use, sterile

Therapak - 07312058462673

Therapak Acetic Acid 24 Hour Collection (CS/24)
Therapak LLC
ACSK38533
In Commercial Distribution

  • 07312058462673 ()
ACSK38533

  • 24-hour urine specimen container IVD, preservative

BLOXR - 10811042030583

XPF® Patient Protection Shield, 24" x 24"
BLOXR Solutions, LLC
100210
In Commercial Distribution

  • 10811042030583 ()


  • Radiation shielding apron

BluEX Lumbar Expandable Cage System - 08809986465870

BluEX-A (24 X 32 X 24 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-2425S
In Commercial Distribution

  • 08809986465870 ()


  • Metallic spinal interbody fusion cage

AMICUS Separator - 04086000100137

Automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Fresenius Kabi AG
6R4580R
In Commercial Distribution

  • 04086000100137 ()
6R4580R

  • Apheresis system

AMICUS Separator - 04086000100120

Automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Fresenius Kabi AG
6R4580
In Commercial Distribution

  • 04086000100120 ()
6R4580

  • Apheresis system

Invenia - 00840682141161

No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS 2.0
In Commercial Distribution

  • 00840682141161 ()


  • Breast ultrasound imaging system

Invenia - 00195278756237

Invenia ABUS Premium
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
ABUS R2.5 Premium
In Commercial Distribution

  • 00195278756237 ()
H5023S1-H5013S1

  • Breast ultrasound imaging system

Invenia - 00195278756138

Invenia ABUS Prime
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
ABUS R2.5 Prime
In Commercial Distribution

  • 00195278756138 ()
H5023S2-H5013S2

  • General-purpose ultrasound imaging system

TITAN IMPLANTS, INC. - 00842448114457

4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG14S2
In Commercial Distribution

  • 00842448114457 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114433

4.8mm Diameter, 6.5mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG12S2
In Commercial Distribution

  • 00842448114433 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114419

4.8mm Diameter, 6.5mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/6TG10S2
In Commercial Distribution

  • 00842448114419 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114365

4.8mm Diameter, 6.5mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/6TG14R1
In Commercial Distribution

  • 00842448114365 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114310

4.8mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG14S2
In Commercial Distribution

  • 00842448114310 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114297

4.8mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG12S2
In Commercial Distribution

  • 00842448114297 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114273

4.8mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG10S2
In Commercial Distribution

  • 00842448114273 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114259

4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-48/4TG8S2
In Commercial Distribution

  • 00842448114259 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114228

4.8mm Diameter, 4.8mm Platform TG Implant Length 14.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG14R1
In Commercial Distribution

  • 00842448114228 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114198

4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10S1
In Commercial Distribution

  • 00842448114198 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114181

4.8mm Diameter, 4.8mm Platform TG Implant Length 10.0mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG10R1
In Commercial Distribution

  • 00842448114181 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114167

4.8mm Diameter, 4.8mm Platform TG Implant Length 8mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-48/4TG8R1
In Commercial Distribution

  • 00842448114167 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114150

4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG14S2
In Commercial Distribution

  • 00842448114150 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114136

4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG12S2
In Commercial Distribution

  • 00842448114136 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114112

4.1mm Diameter, 4.8mm Platform TG Implant Length 10mm Sandblast Collar Height 2.8mm
TITAN IMPLANT INC
IS-41/4TG10S2
In Commercial Distribution

  • 00842448114112 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114068

4.1mm Diameter, 4.8mm Platform TG Implant Length 14mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG14R1
In Commercial Distribution

  • 00842448114068 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114051

4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm Sandblast Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12S1
In Commercial Distribution

  • 00842448114051 ()


  • Dental implant system

TITAN IMPLANTS, INC. - 00842448114044

4.1mm Diameter, 4.8mm Platform TG Implant Length 12mm RBM Collar Height 1.8mm
TITAN IMPLANT INC
IS-41/4TG12R1
In Commercial Distribution

  • 00842448114044 ()


  • Dental implant system
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