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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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microTargeting™ Electrode - 00873263005194

microTargeting Electrode, side by side, tungsten, DZAP(L), sterile
FHC, INC.
MTTWLP(ZK2)-00519
In Commercial Distribution

  • 10873263005191 ()
  • 00873263005194 ()

  • Length: 252 Millimeter
  • Impedance: Megaohms
MTTWLP(ZK2)

  • Depth electrode

microTargeting™ Electrode - 00873263005040

microTargeting(TM) Electrode, array, differential, 1 Meg, sterile, for Nexframe
FHC, INC.
MER-5000T-00504
In Commercial Distribution

  • 10873263005047 ()
  • 00873263005040 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 244.22 Millimeter
  • Length: 234.22 Millimeter
MER-5000T

  • Depth electrode

microTargeting™ Electrode - 00873263004722

microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(SP)(AR5)-00472
In Commercial Distribution

  • 10873263004729 ()
  • 00873263004722 ()

  • Length: 266.5 Millimeter
  • Length: 5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
MTDWZP(SP)(AR5)

  • Depth electrode

microTargeting™ Electrode - 00873263004661

microTargeting Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(SP)(AR1)-00466
In Commercial Distribution

  • 10873263004668 ()
  • 00873263004661 ()

  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
MTDWZP(SP)(AR1)

  • Depth electrode

microTargeting™ Electrode - 00873263004647

microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(NS)(SL2)-00464
In Commercial Distribution

  • 10873263004644 ()
  • 00873263004647 ()

  • Length: 10 Millimeter
  • Length: 274.65 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 258 Millimeter
MTDWZP(NS)(SL2)

  • Depth electrode

microTargeting™ Electrode - 00873263004623

microTargeting(TM) Electrode, differential, tungsten, DZAP(Z), sterile
FHC, INC.
MTDWZP(NS)(SK2)-00462
In Commercial Distribution

  • 10873263004620 ()
  • 00873263004623 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 243.65 Millimeter
  • Length: 227 Millimeter
MTDWZP(NS)(SK2)

  • Depth electrode

SYNCHROMED® II - 00643169508156

PUMP 8637-40 SYNCHMED II 40ML POTTED FTS
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169508156 ()


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00643169508149

PUMP 8637-20 SYNCHMED II 20ML POTTED FTS
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169508149 ()


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED ® II - 00643169100831

PUMP 8637-20 SYNCHMED II 20ML PF
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169100831 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED ® II - 00643169100824

PUMP 8637-40 SYNCHMED II 40ML PF
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169100824 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

PMT® CORPORATION - SPHENOIDAL - 10650551092862

SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122
In Commercial Distribution

  • 10650551092862 ()
  • 00650551092865 ()
2122

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092855

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09
In Commercial Distribution

  • 10650551092855 ()
  • 00650551092858 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-09

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092848

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05
In Commercial Distribution

  • 10650551092848 ()
  • 00650551092841 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-05

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092831

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03
In Commercial Distribution

  • 10650551092831 ()
  • 00650551092834 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092824

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03
In Commercial Distribution

  • 10650551092824 ()
  • 00650551092827 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-31-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092817

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03
In Commercial Distribution

  • 10650551092817 ()
  • 00650551092810 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092800

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03
In Commercial Distribution

  • 10650551092800 ()
  • 00650551092803 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03

  • Depth electrode

SynchroMed® II - 00643169530126

PUMP 8637-40 SYNCHMED II 40ML DLC MOTOR
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169530126 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

SynchroMed® II - 00643169530119

PUMP 8637-20 SYNCHMED II 20ML DLC MOTOR
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169530119 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00643169630512

PUMP 8637-40 SYNCHMED II 40ML EMAN SYMBL
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169630512 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00643169630505

PUMP 8637-20 SYNCHMED II 20ML EMAN SYMBL
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169630505 ()

  • Reservoir Volume 20 mL


  • Implantable intrathecal infusion pump, programmable

HOC COLLECTION VIAL 30ML - 03700111400863

Device for oocyte collection
LABORATOIRE CCD
HOC COLLECTION VIAL 30ML
In Commercial Distribution

  • 03700111425866 ()
  • 03700111400863 ()

  • Total Volume: 30 Milliliter
1302001

  • Assisted reproduction cryotube

CryoTip® - 00893727002118

CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube

inFlow Intraurethral Valve-Pump - 08625630003034

Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003027

Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003003

Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003002

Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump

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

CODMAN - 10886704072881

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Cerenovus, Inc.
AP-04009
Not in Commercial Distribution

  • 20886704072888 ()
  • 10886704072881 ()
AP04009

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704044109

Models 400 and 550 Implantable Infusion Pump Refill Kit
Cerenovus, Inc.
IP-40820
Not in Commercial Distribution

  • 10886704044109 ()
IP40820

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704044093

MODEL 400 REFILL TUBING SET
Cerenovus, Inc.
IP40812
Not in Commercial Distribution

  • 10886704044093 ()
IP40812

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043829

3000 Series High Temperature Drape for use with CODMAN O.R. Heater AP-09100
Cerenovus, Inc.
AP-09150
Not in Commercial Distribution

  • 20886704043826 ()
  • 10886704043829 ()
AP09150

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043775

FOR USE WITH CODMAN 3000 series Refill Kit - CODMAN 3000 Series Implantable Drug Delivery System
Medos International Sàrl
AP-07014
Not in Commercial Distribution

  • 10886704043775 ()
AP07014

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043768

FOR USE WITH: CODMAN 3000 Series Implantable Pump Operating Room Prep Kit Contents: (1) 2.54cm (1 inch) Huber Needle (REF AP-04009) (1) Special Bolus Needle (REF AP-04013-5) (1) Empty Syringe Barrel with Lid assembled to a 33cm (13 inch) Microbore Tubing Set with Clamp Approximate priming volume 0.3mL (3) Instructions for Use Posters
Medos International Sàrl
AP-07004
Not in Commercial Distribution

  • 10886704043768 ()
AP07004

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043744

Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 2inch (5 cm)
Medos International Sàrl
AP-04032-5
Not in Commercial Distribution

  • 20886704043741 ()
  • 10886704043744 ()
AP040325

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043737

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04030
Not in Commercial Distribution

  • 20886704043734 ()
  • 10886704043737 ()
AP04030

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043720

Special Bolus Needle for use with CODMAN 3000 series Drug Delivery System Straight Length 1 3/8inch (3.5 cm)
Medos International Sàrl
AP-04013-5
Not in Commercial Distribution

  • 20886704043727 ()
  • 10886704043720 ()
AP040135

  • Implantable intrathecal infusion pump, nonprogrammable

NA - 10886704043713

Non-coring (Huber) Needle for use with CODMAN 3000 Series Drug Delivery System
Medos International Sàrl
AP-04011
Not in Commercial Distribution

  • 20886704043710 ()
  • 10886704043713 ()
AP04011

  • Implantable intrathecal infusion pump, nonprogrammable

CODMAN - 10886704043621

Constant Flow Implantable Pump With Bolus Safety Valve and Operating Room Prep Kit
Cerenovus, Inc.
AP-03000UL
Not in Commercial Distribution

  • 10886704043621 ()
AP03000UL

  • Implantable intrathecal infusion pump, nonprogrammable
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