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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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Empower 2® - 00190746008375

DB BKT SL EMPOWER INTERACT UR 1ST BICUSPID 018 T-7 A=0 R=0 BX PAD
AMERICAN ORTHODONTICS CORPORATION
475-18-91407
In Commercial Distribution

  • 00190746008375 ()
475-18-91407

  • Orthodontic bracket, metal

ColoScreen Developer 2 - M52550780

No Description
HELENA LABORATORIES CORPORATION
5078
In Commercial Distribution

  • M52550781 ()
  • M52550780 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical

FreeStyle Libre 2 - 00357599804008

FreeStyle Libre 2 Flash Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
71952
In Commercial Distribution

  • 30357599804009 ()
  • 00357599804008 ()
71952

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

SomnoGuard AP 2 - 04260383460297

No Description
Tomed GmbH
03050200
In Commercial Distribution

  • 04260383460297 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

FreeStyle Libre 2 - 00357599805005

FreeStyle Libre 2 Flash Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
71951
In Commercial Distribution

  • 30357599805006 ()
  • 00357599805005 ()
71951

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

FreeStyle Libre 2 - 00357599803001

FreeStyle Libre 2 Flash Glucose Monitoring System Reader
ABBOTT DIABETES CARE INC
71953
In Commercial Distribution

  • 30357599803002 ()
  • 00357599803001 ()
71953

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

PAD, ARMBOARD, 2" - 00842430100376

This pad is designed for use with various Mizuho OSI Armboards. Dimensions: 24x6x2 inches. Made with Tempur-Pedic® Medical materials
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5356-7000
In Commercial Distribution

  • 00842430100376 ()
5356-7000

  • Operating table mattress, basic

Bone Splitter 2 - 08809854020033

Common Ø7.0/ L=32.8
Megagen Implant Co. Ltd
BSP02
In Commercial Distribution

  • 08809854020033 ()
BSP02

  • Surgical screwdriver, reusable

Endovapor®2 - 04250337103974

joimax® Endovapor®2 Device Dual High Frequency System
Joimax GmbH
JEVD0202
In Commercial Distribution

  • 04250337103974 ()


  • Electrosurgical system generator

NOMAD Pro 2 - D090101329300

X-Ray Tubehead, DEXIS Nomad Pro 2, GBL
Dental Imaging Technologies Corporation
1.013.2930
In Commercial Distribution



  • Diagnostic x-ray system generator, hand-held
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