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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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Avalon - 00190730000460

Avalon Com Roth 018 L1/2 Rx -6° Tor. 0° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A18-741
Not in Commercial Distribution

  • 00190730000460 ()


  • Orthodontic bracket, plastic, single-use

8-Chamber Arm & Shoulder Sleeve - Medium, Left - 00812311029119

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L
In Commercial Distribution

  • 00812311029119 ()


  • Multi-chamber venous compression system garment, reusable

8-Chamber Arm & Shoulder Sleeve - Medium, Left - 00812311020062

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Bio Compression Systems, Inc
G8-3035-SH-M-L-BT
In Commercial Distribution

  • 00812311020062 ()


  • Multi-chamber venous compression system garment, reusable

HANSATON stream remote 5.X - 07613389610932

A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software

Meridian Medical - 00815067040179

APP PAD W/O HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002
In Commercial Distribution

  • 30815067040170 ()
  • 00815067040179 ()


  • Alternating-pressure bed mattress overlay, reusable

SoNoNav® Calibration App - 00643169183407

SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system

Halo Systems - 05690977308695

OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution

  • 05690977308695 ()
515500V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308688

OB V2 RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400V2
Not in Commercial Distribution

  • 05690977308688 ()
515400V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308671

OB V2 RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300V2
Not in Commercial Distribution

  • 05690977308671 ()
515300V2

  • Cervical spine immobilization head ring

DreamMapper - 00606959054288

DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software
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