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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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Inspire - 00855728005949

The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.
Inspire Medical Systems, Inc.
900-014-003
In Commercial Distribution

  • 00855728005949 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing

OBALON® - 00859810006173

OBALON® Balloon Evacuator - component for use with the OBALON® Balloon
ReShape Lifesciences Inc.
6300-0001
Not in Commercial Distribution

  • 00859810006173 ()


  • Appetite-suppression gastric balloon deployment device/set

OBALON® - 00859810006142

OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon
ReShape Lifesciences Inc.
6200-0001
Not in Commercial Distribution

  • 00859810006142 ()


  • Appetite-suppression gastric balloon deployment device/set

INTERSTIM® - 00643169929005

CABLE 357664 ISTM TEST TWIST LOCK GLOBAL
MEDTRONIC, INC.
357664
In Commercial Distribution

  • 00643169929005 ()


  • Electrical-only medical device connection cable, reusable

INTERSTIM® - 00643169928992

CABLE 357625 ISTM TEST TWIST LOCK GLOBAL
MEDTRONIC, INC.
357625
In Commercial Distribution

  • 00643169928992 ()


  • Electrical-only medical device connection cable, reusable

NA - 00643169565920

CABLE 4819 STERILE
MEDTRONIC, INC.
4819
In Commercial Distribution

  • 00643169565920 ()

  • Length: 6.0 Feet


  • Electrical-only medical device connection cable, reusable

NA - 00643169565913

CABLE 05116 RF CATHETER 12 FT STERILE
MEDTRONIC, INC.
05116
In Commercial Distribution

  • 00643169565913 ()

  • Length: 12.0 Feet


  • Electrical-only medical device connection cable, reusable

INTERSTIM® - 00643169721180

CABLE 357501 MINI HOOK GLOBAL
MEDTRONIC, INC.
357501
In Commercial Distribution

  • 00643169721180 ()


  • Electrical-only medical device connection cable, reusable

NA - 00643169838604

ADAPTOR CABLE 5103 US
MEDTRONIC, INC.
5103
In Commercial Distribution

  • 00643169838604 ()


  • Electrical-only medical device connection cable, reusable

t:slim X2 5.x Insulin Pump - 00853052007981

t:slim X2 5.x Insulin Pump, Replacement, Refurbished
Tandem Diabetes Care, Inc.
1003808
In Commercial Distribution

  • 00853052007981 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system
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