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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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To be attached at the tube saw to provide the required torque to saw the bone.
OSTEOTEC LIMITED
OST-CBG-15
In Commercial Distribution

  • 05060183095694 ()
OST-CBG-15

  • Surgical instrument handle, non-torque-limiting
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BTS 24V (F)
In Commercial Distribution

  • 00816787020342 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V NV
In Commercial Distribution

  • 00816787020328 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V 901C
In Commercial Distribution

  • 00816787020311 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-BL 24V 800C
In Commercial Distribution

  • 00816787020298 ()


  • Laser Doppler blood flowmeter
No Description
BLINK MEDICAL LIMITED
76-0073
In Commercial Distribution

  • 05060745557127 ()
  • 05060745557110 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
FRANCIS FOREIGN BODY ANGLED FLAG SHAPED TIP
SONTEC INSTRUMENTS, INC.
11-3750
In Commercial Distribution

  • 00192896012608 ()
11-3750

  • Eye spud
Double Ended Foreign Body Spud
AURORA SURGICAL, LLC
AS4-026
In Commercial Distribution

  • 08175700114066 ()
AS4-026

  • Ophthalmic surgical probe, reusable
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Spirobank Oxi
In Commercial Distribution

  • 08052990321711 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
Smart Spirometer and Oximeter connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
Smart One Oxi
In Commercial Distribution

  • 08052990321704 ()


  • Expiratory peak flow meter, digital
  • Pulse oximeter
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