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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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CONFORMat Evolution - B970CEC5330533120

Includes 2 Evolution Handles, CONFORMat Clinical Software CD with 5330, 5331, and 5330_5331 Maps, (1) 5330-5 and (1) 5331-5 Sensors, System Carrying Case, Sensor Carrying Tube, Quick Start Guide, 1 Web-based Training Session (USA Only)
Tekscan, Inc.
CONFORMat 2 System with Clinical Software
In Commercial Distribution

  • B970CEC5330533120 ()
CEC5330-5331-2

  • Body-surface pressure mapping system

BITE REG INTRAORAL TIP CD 96 - J014660009050

Syringe, Restorative and Impression Material
Kulzer GmbH
66000905
In Commercial Distribution

  • J014660009051 ()
  • J014660009050 ()
66000905

  • Dental material mixing nozzle

CD HORIZON® Fenestrated Screw Set - 00643169679429

DRIVER 7480755T 5.5/6.0 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
7480755T
In Commercial Distribution

  • 00643169679429 ()


  • Orthopaedic implant driver

CD HORIZON® Fenestrated Screw Set - 00643169679412

DRIVER 7480745T 4.75 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
7480745T
In Commercial Distribution

  • 00643169679412 ()


  • Orthopaedic implant driver

CD HORIZON® Fenestrated Screw Set - 00643169679405

SHAFT 7480741T ADAPTER DRIVER QC SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
7480741T
In Commercial Distribution

  • 00643169679405 ()


  • Orthopaedic implant driver

BPMS Evolution - B970BCE533020

Includes 2 Evolution Handles, BPMS Clinical Software CD with (2) 5330 Sensor Map(s), Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5330 Sensors, and 1 Training Session (USA Only)
Tekscan, Inc.
BPMS 2 System (5330 Sensors)
In Commercial Distribution

  • B970BCE533020 ()
BCE5330-2

  • Body-surface pressure mapping system

Welch Allyn, Inc. - 00732094115147

Welch Allyn Harvey DLX Cardiology Stethoscope with Stainless Steel Triple-Head Chestpiece (Low-Frequency Bell, Adult Diaphragm, and Pediatric Diaphragm), Dual Lumen Latex-Free Tubing, Harvey Heart Sounds CD, Harvey DLX Accessory Kit (#5079-315); 28 in/71.1 cm; Black
WELCH ALLYN, INC.
901039
In Commercial Distribution

  • 00732094115147 ()
5079-321S

  • Mechanical external stethoscope

Welch Allyn, Inc. - 00732094115086

Welch Allyn Harvey DLX Cardiology Stethoscope with Stainless Steel Triple-Head Chestpiece (Low-Frequency Bell, Adult Diaphragm, and Pediatric Diaphragm), Dual Lumen Latex-Free Tubing, Harvey Heart Sounds CD, Harvey DLX Accessory Kit (#5079-315); 28 in/71.1 cm; Burgundy
WELCH ALLYN, INC.
901039
In Commercial Distribution

  • 00732094115086 ()
5079-322S

  • Mechanical external stethoscope

Welch Allyn, Inc. - 00732094115031

Welch Allyn Harvey DLX Cardiology Stethoscope with Stainless Steel Triple-Head Chestpiece (Low-Frequency Bell, Adult Diaphragm, and Pediatric Diaphragm), Dual Lumen Latex-Free Tubing, Harvey Heart Sounds CD, Harvey DLX Accessory Kit (#5079-315); 28 in/71.1 cm; Navy
WELCH ALLYN, INC.
901039
In Commercial Distribution

  • 00732094115031 ()
5079-323S

  • Mechanical external stethoscope

Walkway Evolution - B970VH20

Includes 2 Evolution Handles, Walkway Software CD with 5101D Map and 3 Factory Equilibration Files, Help File and PDF of System Manual, (2) 5101 Sensors (pre-assembled into a single floor display), and 1 Training Session (USA Only)
Tekscan, Inc.
Very HR Walkway 2 System
In Commercial Distribution

  • B970VH20 ()
VH2

  • Body-surface pressure mapping system
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