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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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The proposed Electrodes with snap / Electrodes with pigtail are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydro gel, no securing materials are required to secure the product to the patient’s skin. The proposed product mainly consists of electrode pad and snap or pigtail. The electrode pad is available in Round Shape Electrode, Rectangular Shape Electrode, Palm Shape Electrode, Elliptical Shape Electrode, and Calabash Shape Electrode. All patient contacted materials are complied with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Shenzhen Konmed Technology Co., Ltd.
KM-803
In Commercial Distribution

  • 06970935830079 ()


  • Transcutaneous electrical stimulation electrode, single-use
No Description
W.H. Holden, Inc.
90-73OS-040HP
In Commercial Distribution

  • D9289073OS040HP0 ()


  • Carbide dental bur, reusable
No Description
AB MEDICA
C35-IP-2DS-33
In Commercial Distribution

  • E496C35IP2DS330 ()
C35-IP-2DS-33

  • Endoscopic electrosurgical electrode, monopolar, reusable
No Description
AB MEDICA
C35-IP-2DC-33
In Commercial Distribution

  • E496C35IP2DC330 ()
C35-IP-2DC-33

  • Endoscopic electrosurgical electrode, monopolar, reusable
The collimator is intended for a larger compression height range with breasts of larger size.
Philips Digital Mammography Sweden AB
1024280
In Commercial Distribution

  • 00884838081093 ()


  • Fixed-aperture diagnostic x-ray system collimator
LATITUDE ® Communicator
BOSTON SCIENTIFIC CORPORATION
6482
In Commercial Distribution

  • 00802526516146 ()


  • Multi-hole nuclear medicine system collimator, high-energy
LATITUDE ® Communicator with Wand
BOSTON SCIENTIFIC CORPORATION
6481
In Commercial Distribution

  • 00802526480485 ()


  • Multi-hole nuclear medicine system collimator, high-energy
BREAST EXPANDER, WIDE BASE OVAL SHAPE, SMOOTH SURFACE, INTERNAL PORT, 2-STAGE, SUTURE TABS, 12X10CM, 450CC FILL VOLUME, 9CM PROJECTION
PMT CORPORATION
3611-204-2I-ST
In Commercial Distribution

  • 00650551002154 ()


  • Skin-port tissue expander
Softspan™ Tissue Expander, Flat Kidney Shape, Integrated Precision Point™ Magnetic Injection Port System,Textured Surface, Reinforced Base
SPECIALTY SURGICAL PRODUCTS INC
SIE-FK-74
Not in Commercial Distribution

  • M746SIEFK740 ()

  • Width: 7 Centimeter
SIE-FK-74

  • Skin-port tissue expander
Softspan™ Tissue Expander, Flat Kidney Shape, Integrated Precision Point™ Magnetic Injection Port System,Textured Surface, Reinforced Base
SPECIALTY SURGICAL PRODUCTS INC
SIE-FK-127
Not in Commercial Distribution

  • M746SIEFK1270 ()

  • Width: 12 Centimeter
SIE-FK-127

  • Skin-port tissue expander
Softspan™ Tissue Expander, Flat Kidney Shape, Integrated Precision Point™ Magnetic Injection Port System,Textured Surface, Reinforced Base
SPECIALTY SURGICAL PRODUCTS INC
SIE-FK-106
Not in Commercial Distribution

  • M746SIEFK1060 ()

  • Width: 10 Centimeter
SIE-FK-106

  • Skin-port tissue expander
HEALING SCREW Ø6.0 H4 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS640
In Commercial Distribution

  • 03663394001489 ()

  • Coronary Height: 2.0 Millimeter
  • Gingival Height: 4.5 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
HEALING SCREW Ø6.0 H3 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS630
In Commercial Distribution

  • 03663394001472 ()

  • Coronary Height: 2.0 Millimeter
  • Gingival Height: 3.5 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
HEALING SCREW Ø6.0 H1 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS610
In Commercial Distribution

  • 03663394001458 ()

  • Coronary Height: 2.0
  • Gingival Height: 1.5 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
HEALING SCREW Ø5.0 H2 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS520
In Commercial Distribution

  • 03663394001427 ()

  • Coronary Height: 2.0 Millimeter
  • Gingival Height: 2.5 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
HEALING SCREW Ø5.0 H0 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS500
In Commercial Distribution

  • 03663394001403 ()

  • Coronary Height: 2.0 Millimeter
  • Gingival Height: 0.75 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
HEALING SCREW Ø4.0 H3 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS430
In Commercial Distribution

  • 03663394001380 ()

  • Coronary Height: 2.0 Millimeter
  • Gingival Height: 3.5 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
HEALING SCREW Ø4.0 H1 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS410
In Commercial Distribution

  • 03663394001366 ()

  • Coronary Height: 2.0 Millimeter
  • Gingival Height: 1.5 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
HEALING SCREW Ø3.4 H3 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS330
In Commercial Distribution

  • 03663394001335 ()

  • Coronary Height: 2.0 Millimeter
  • Gingival Height: 3.5 Millimeter
  • Outer Diameter: 3.4 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
HEALING SCREW Ø6.0 H2 Sealing of implant conical connection during bone healing. Preparing gingiva to the permanent restoration shape.
ETABLISSEMENTS ANTHOGYR
OPHS620
In Commercial Distribution

  • 03663394001465 ()

  • Coronary Height: 2.0 Millimeter
  • Gingival Height: 2.5 Millimeter
  • Outer Diameter: 6.0 Millimeter


  • Dental implant suprastructure, temporary, preformed, single-use
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