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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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No Description
Directa AB
10
In Commercial Distribution

  • 17310236092107 ()
609210

  • Preformed dental crown, temporary
TECHNO CUT PRO STAINLESS STEEL STERILE CARTRIDGE BLADE MANAGEMENT SYSTEM # 10 INDIVIDUALLY PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 58904233144715 ()
  • 18904233144717 ()
  • 08904233144710 ()
04471

  • Manual scalpel blade, single-use
TECHNO CUT HIGH CARBON STAINLESS STEEL STERILE SURGICAL BLADE # 10 WITH SILICON COATING INDIVIDUALLY PACKED
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233137402 ()
  • 18904233137405 ()
  • 58904233137403 ()
  • 08904233137408 ()
03740

  • Manual scalpel blade, single-use
STAINLESS STEEL NON STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #10 BULK PACKED MYCO REORDER # 6000CST-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233122965 ()
  • 18904233122968 ()
  • 58904233122966 ()
  • 08904233122961 ()
02296

  • Scalpel, single-use
GLASS VAN STAINLESS STEEL STERILE SURGICAL BLADE #10 INDIVIDUALLY PACKED MYCO REORDER # 3001T-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233118340 ()
  • 18904233118343 ()
  • 58904233118341 ()
  • 08904233118346 ()
01834

  • Manual scalpel blade, single-use
GLASS VAN CARBON STEEL STERILE SURGICAL BLADE #10 INDIVIDUALLY PACKED MYCO REORDER # 2001T-10
NIRAJ INDUSTRIES PRIVATE LIMITED
#10
In Commercial Distribution

  • 28904233118319 ()
  • 18904233118312 ()
  • 58904233118310 ()
  • 08904233118315 ()
01831

  • Manual scalpel blade, single-use
No Description
Chemoment Materials Co., Ltd.
10
In Commercial Distribution

  • 06976009581106 ()


  • Silicone dental impression material
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Anovo Surgeon Console comprised of Arm Controllers (Joysticks and Thumbsticks), an Adjustable Controllers Stand, a PC with Touch Screen, Manual Release Tool and the Power Adapter, and allowing the operating surgeon to operate the Anovo Instrument Arms. There are two sets of Arm Controllers for the Anovo System: two Thumbsticks and two ARMS Controllers. The ARMS Controllers are enabled only when the system is at “resume” state and allow for the accurate control of the Anovo Instrument ARMS during the surgical procedure. Like the Anovo Instrument Arm, each ARMS Controllers has three joints: wrist, elbow and shoulder, so that each Anovo Instrument ARM moves accordingly to Controller's movement. The surgeon-held Controller handle is above the elbow joint and allows for multiple functionality transitions.
MOMENTIS SURGICAL LTD
10
In Commercial Distribution

  • 07290018151013 ()
  • 17290018151010 ()
FP-03-0003

  • Endoscopic electromechanical surgical system
Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
10#
In Commercial Distribution

  • 26946430401278 ()
  • 16946430401271 ()
  • 06946430401274 ()


  • Oropharyngeal airway, single-use
Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
10#
In Commercial Distribution

  • 26946430401094 ()
  • 16946430401097 ()
  • 06946430401090 ()


  • Oropharyngeal airway, single-use
No Description
Sterilance Medical (Suzhou) Inc.
10#
In Commercial Distribution

  • 36945630112387 ()
  • 16945630112383 ()
  • 06945630112386 ()


  • Manual scalpel blade, single-use
Carbon Steel Surgical Blade,100pcs/box,10#
Sterilance Medical (Suzhou) Inc.
10#
In Commercial Distribution

  • 06945630101816 ()
  • 16945630101813 ()


  • Manual scalpel blade, single-use
Emesis Basin, 26 Oz, Seamless Design, Dimensions 9-7/8" X 4-1/2" X 2-1/8"
Med Saver, Inc.
10
In Commercial Distribution

  • 00194613019600 ()


  • General-purpose bowl, reusable
No Description
Biomedica ADI Inc.
815L
In Commercial Distribution

  • 00850201006123 ()
  • 10850201006120 ()
815L

  • Lupus anticoagulant marker IVD, kit, clotting
No Description
Biomedica ADI Inc.
810
In Commercial Distribution

  • 00850201006017 ()
  • 10850201006014 ()
810

  • Lupus anticoagulant marker IVD, kit, clotting
ALPT23 10
UTAK LABORATORIES, INC.
ALPT23_10
In Commercial Distribution

  • B800ALPT23105 ()
  • B800ALPT23100 ()

  • Total Volume: 1 Milliliter
ALPT23_10

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
ergoline GmbH
193001
In Commercial Distribution

  • 04059358002248 ()

  • Width: 90 Centimeter
  • Length: 220 Centimeter
  • Height: 180 Centimeter
  • Weight: 240 Kilogram


  • Bicycle ergometer
The one device that has DI number included 100 strips
DFI CO.,LTD
0004
In Commercial Distribution

  • 08806141302070 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
The one device that DI number included 100 strips
DFI CO.,LTD
0024
In Commercial Distribution

  • 08806141301998 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844009864 ()

  • 18x15x40mm
NV101840

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844009857 ()

  • 16x15x40mm
NV101640

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844009840 ()

  • 14x15x40mm
NV101440

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844009833 ()

  • 12x15x40mm
NV101240

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844008348 ()

  • 16x15x44mm
NV101644

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844008324 ()

  • 14x15x44mm
NV101444

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000915 ()

  • 18x43mm
SK101843

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000908 ()

  • 18x38mm
SK101838

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000892 ()

  • 16x43mm
SK101643

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000885 ()

  • 16x38mm
SK101638

  • Polymeric spinal interbody fusion cage
The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ implants have a hollow, slightly curved frame with tapered edges. The frame is made from PEEK-OPTIMA®. SEMIAL® spinal implants have a semi-cylindrical form and are hollow. The implant is made from PEEK-OPTIMA®. The provision of varying heights, together with a wedge shaped option, allow better lordosis control. The TETRIS® implants (PEEK and Titanium) are hollow having a rectangular frame with lateral fenestrations. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies. These implants are available in a variety of dimensional and angular sizes. This enables the surgeon to choose the size suited to the individual pathology and anatomy and condition. The MOBIS, NOVAL, SEMIAL and PEEK TETRIS devices are manufactured from polyetheretherketone (PEEK-OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker pins are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3 or tantalum as described by ASTM F560. The Titanium TETRIS devices are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136 / ISO 5832-3. The KIMBA® and KIMBA® mini devices are manufactured from ECF PEEK OPTIMA (Invibio™).
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844000878 ()

  • 14x43mm
SK101443

  • Polymeric spinal interbody fusion cage
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