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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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SPHERO FLEX - 08059224052144

Sphero Flex is designed as an endosseous dental implant retentive component used to retain a partial denture. Sphero Flex is intended to screwed onto an endosseous implant in the mandible or maxilla.
RHEIN 83 SRL
SPHERO FLEX CERTAIN 3I ø 5 h.5 RIV.TiN
In Commercial Distribution

  • 08059224052144 ()
109IIC55R

  • Dental implant suprastructure, permanent, preformed

DEKA SmartXide UltraSpeed - 08057017760245

DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.
EL.EN. SPA
M110G1
In Commercial Distribution

  • 08057017760245 ()
M110G1

  • Dental carbon dioxide laser system

Integra® - 10381780246930

Integra®Surgical Instruments The Kolbel retractor frame is the base of the retractor, in which different size blades are attached. The retractor is used to withdraw muscle and tissue for exposure.
Ascension Orthopedics, Inc.
RET-920-60
In Commercial Distribution

  • M269RET920601 ()
  • 10381780246930 ()

  • Sm Md Lg
RET-920-60

  • Hand-held surgical retractor, reusable

FUJIFILM - 04547410330205

Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
FUJIFILM CORPORATION
EG-530UR2
In Commercial Distribution

  • 04547410330205 ()
  • 14547410330202 ()


  • Flexible ultrasound gastroduodenoscope

FUJIFILM - 04547410330199

Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UT2 is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
FUJIFILM CORPORATION
EG-530UT2
In Commercial Distribution

  • 04547410330199 ()
  • 14547410330196 ()


  • Flexible ultrasound gastroduodenoscope

Elos Accurate® Scan Body - 05712821010681

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 13B-A
In Commercial Distribution

  • 05712821010643 ()
  • 05712821010681 ()
IO 13B-A

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821010674

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 13A-A
In Commercial Distribution

  • 05712821010636 ()
  • 05712821010674 ()
IO 13A-A

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821010667

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 12A-B
In Commercial Distribution

  • 05712821010629 ()
  • 05712821010667 ()
IO 12A-B

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821010650

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 12A-A
In Commercial Distribution

  • 05712821010612 ()
  • 05712821010650 ()
IO 12A-A

  • Dental implant suprastructure, temporary, preformed, reusable

Elos Accurate® Scan Body - 05712821006479

The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 2B-D SA
In Commercial Distribution

  • 05712821006479 ()
  • 05712821008619 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
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