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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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DiamondCrown-DCBLOK(CADCAM)-I-10mm A1/B1 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-10mm A1/B1
In Commercial Distribution

  • 00860004379928 ()
DCBK701

  • Dental implant suprastructure, permanent, preformed
DiamondCrown-DCBLOK(CADCAM)-I-15mm A2 - DRM-Laminate/Veneer-Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant- Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-15mm A2
In Commercial Distribution

  • 00860004379911 ()
DCBK706

  • Dental implant suprastructure, permanent, preformed
DiamondCrown-DCBLOK(CADCAM)-I-15mm A1/B1 - DRM-Laminate/Veneer-Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeram Restorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant-Superstructure System, Permanent, Preformed
DRM RESEARCH LABORATORIES INC
DCBLOK-I-15mm A1/B1
In Commercial Distribution

  • 00860004379904 ()
DCBK705

  • Dental implant suprastructure, permanent, preformed
Mid-Urethral Sling Assembly, Flat Needles
Athena Surgical LLC
9002-1
In Commercial Distribution

  • 00860003619827 ()
  • 10860003619824 ()
  • 00860003619834 ()

  • Width: 1.1 Centimeter
  • Length: 45 Centimeter


  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer
Mid-Urethral Sling Assembly, Round Needles
Athena Surgical LLC
9001-1
In Commercial Distribution

  • 20860003619814 ()
  • 00860003619810 ()
  • 10860003619817 ()

  • Width: 1.1 Centimeter
  • Length: 45 Centimeter


  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer
Instrument Handle
Athena Surgical LLC
9003
In Commercial Distribution

  • 00860003619803 ()
  • 90860003619837 ()


  • Female stress urinary incontinence surgical mesh-sling, synthetic polymer
ClearFit VDI Large
LONGEVITI NEURO SOLUTIONS LLC
171718
In Commercial Distribution

  • 00860003416310 ()


  • Cranial resinous compound
ClearFit VDI Standard
LONGEVITI NEURO SOLUTIONS LLC
171716
In Commercial Distribution

  • 00860003416303 ()


  • Cranial resinous compound
Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics and software.
Canary Medical USA LLC
43-5570-030-14
In Commercial Distribution

  • 00860003118399 ()


  • Knee femur stem prosthesis
The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System.
Canary Medical USA LLC
43-5570-058-14
In Commercial Distribution

  • 00860003118306 ()


  • Knee femur stem prosthesis
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