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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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Macro Depth Electrode - 00841823109705

No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109699

No Description
Ad-Tech Medical Instrument Corporation
8
In Commercial Distribution

  • 00841823109699 ()
BF09R-SP05X-0BE

  • Depth electrode

Macro Depth Electrode - 00841823109682

No Description
Ad-Tech Medical Instrument Corporation
7
In Commercial Distribution

  • 00841823109682 ()
BF09R-SP21X-0CC

  • Depth electrode

Macro Depth Electrode - 00841823109675

No Description
Ad-Tech Medical Instrument Corporation
6
In Commercial Distribution

  • 00841823109675 ()
BF09R-SP61X-0CC

  • Depth electrode

Macro Depth Electrode - 00841823109668

No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109651

No Description
Ad-Tech Medical Instrument Corporation
4
In Commercial Distribution

  • 00841823109651 ()
BF10R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109644

No Description
Ad-Tech Medical Instrument Corporation
3
In Commercial Distribution

  • 00841823109644 ()
BF10R-SP61X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109637

No Description
Ad-Tech Medical Instrument Corporation
2
In Commercial Distribution

  • 00841823109637 ()
BF12R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109620

No Description
Ad-Tech Medical Instrument Corporation
1
In Commercial Distribution

  • 00841823109620 ()
BF12R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109613

No Description
Ad-Tech Medical Instrument Corporation
0
In Commercial Distribution

  • 00841823109613 ()
BF12R-SP61X-0C3

  • Depth electrode

Activator - 08625630003010

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump

Activator - 08625630003001

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump

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

D630 Upgrade - 00840682145503

B615 to D630 upgrade kits option with new ROTOR
Hangwei GE Medical Systems Co., Ltd.
H2401XF
In Commercial Distribution

  • 00840682145503 ()
H2401XF

  • Stationary gamma camera system

NM - 00840682140829

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00840682140829 ()


  • Stationary gamma camera system

Discovery - 00840682139274

D630 NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
NM 630
In Commercial Distribution

  • 00840682139274 ()


  • Stationary gamma camera system

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

Discovery 630 - 00840682115292

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JY
In Commercial Distribution

  • 00840682115292 ()


  • Stationary gamma camera system

Discovery NM 530c - 00840682105286

UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


  • Stationary gamma camera system

Brivo 615 - 00840682117869

No Description
Hangwei GE Medical Systems Co., Ltd.
5376496-15
In Commercial Distribution

  • 00840682117869 ()


  • Stationary gamma camera system

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
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