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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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Entrant™ - 05415067049414

VR Implantable Cardioverter Defibrillator
ST. JUDE MEDICAL, INC.
CDVRA300T
In Commercial Distribution

  • 05415067049414 ()
CDVRA300T

  • Single-chamber implantable defibrillator

HeartMate™ - 05415067038609

Power Module Backup Battery
Thoratec Corporation
109200
In Commercial Distribution

  • 05415067038609 ()
109200

  • Secondary battery

TactiSys™ - 07640157990194

Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer

NA - 10886704028444

Intraspinal Catheter Kit
Medos International Sàrl
60-2918US
Not in Commercial Distribution

  • 10886704028444 ()
602918US

  • Spinal port/catheter

NA - 10886704028420

Pump Catheter
Medos International Sàrl
60-2914US
Not in Commercial Distribution

  • 10886704028420 ()
602914US

  • Spinal port/catheter

NA - 10886704078845

Models 400 and 550 Implantable Infusion Pump Refill Kit Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set with Removable Injection Site (1) Stopcock (2) Huber Point Needles 22 Gauge x 1inch (2.54 cm) (2) Huber Point Needles 22 Gauge x 1.5inch (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (2) Pump Templates (2) Adhesive Bandages (1) Refill Worksheet (1) Set of INSTRUCTIONS FOR USE
Medos International Sàrl
IP40820US
Not in Commercial Distribution

  • 10886704078845 ()
IP40820US

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704078838

FOR USE WITH CODMAN 3000 series IMPLANTABLE DRUG DELIVERY SYSTEM Contents: (1) 50 ml Calibrated Syringe Barrel (1) Tubing Set (1) Stopcock (2) Huber Point Needles: 22 Gauge x 1.5" (3.8 cm) (6) Gauze Pads (1) Fenestrated Drape (1) Data Sticker (2) Adhesive Bandages (1) Refill Worksheet (1) INSTRUCTIONS FOR USE (2) Instruction Posters
Medos International Sàrl
AP07014US
Not in Commercial Distribution

  • 10886704078838 ()
AP07014US

  • Implantable intrathecal infusion pump, nonprogrammable

SURESTREAM - 10886704072560

Intraspinal Catheter Connector with Strain Relief Sleeve
Medos International Sàrl
70029US
Not in Commercial Distribution

  • 10886704072560 ()
70029US

  • Spinal port/catheter

SURESTREAM - 10886704072553

Intraspinal Catheter Kit A.1 SureStream Catheter;19-gauge;with Guide Wire B.1 Catheter-threading guide C.1 SureStream Connector;titanium D. Anchors 1 each of 4 styles
Medos International Sàrl
70020US
Not in Commercial Distribution

  • 10886704072553 ()
70020US

  • Spinal port/catheter

MEDSTREAM - 10886704072072

Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable
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