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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 - 00855728005796

The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-001
In Commercial Distribution

  • 00855728005796 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing

STERILE PermaLoc Electrode, 60cm - 00852184003144

No Description
Synapse Biomedical, Inc.
21-0017-99
In Commercial Distribution

  • 00852184003144 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, active

CODMAN® CERTAS® Plus - 10381780535867

CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with SIPHONGUARD®, Accessories and Unitised BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, and Information Manual
Integra LifeSciences Switzerland Sàrl
828827PL
In Commercial Distribution

82-8827PL

  • Cerebrospinal fluid shunt valve

CODMAN® CERTAS® Plus - 10381780535843

CODMAN® CERTAS® Plus Programmable Valve Right Angle Valve with Accessories and Unitised BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, and Information Manual
Integra LifeSciences Switzerland Sàrl
828823PL
In Commercial Distribution

82-8823PL

  • Cerebrospinal fluid shunt valve

CODMAN® CERTAS® Plus - 10381780535829

CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with SIPHONGUARD®, Accessories and Unitised BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Integra LifeSciences Switzerland Sàrl
828817PL
In Commercial Distribution

82-8817PL

  • Cerebrospinal fluid shunt valve

CODMAN® CERTAS® Plus - 10381780535805

CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with Accessories and Unitised BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Integra LifeSciences Switzerland Sàrl
828813PL
In Commercial Distribution

82-8813PL

  • Cerebrospinal fluid shunt valve

CODMAN® CERTAS® Plus - 10381780535430

CODMAN CERTAS® Plus Programmable Valve Inline Valve with SIPHONGUARD®, Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Integra LifeSciences Switzerland Sàrl
828807PL
In Commercial Distribution

82-8807PL

  • Cerebrospinal fluid shunt valve

CODMAN® CERTAS® Plus - 10381780535393

CODMAN® CERTAS® Plus Programmable Valve Inline Valve with Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Integra LifeSciences Switzerland Sàrl
828803PL
In Commercial Distribution

82-8803PL

  • Cerebrospinal fluid shunt valve

Strata™ - 00643169840980

SHUNT 46837 STRATA II BURR HOLE
MEDTRONIC PS MEDICAL, INC.
46837
In Commercial Distribution

  • 00643169840980 ()


  • Cerebrospinal fluid shunt valve

Strata™ - 00643169840973

SHUNT 46636 STRATA NSC BURR
MEDTRONIC PS MEDICAL, INC.
46636
In Commercial Distribution

  • 00643169840973 ()


  • Cerebrospinal fluid shunt valve
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