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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SET OF 10 ANCHOR BOLTS, LENGTH 20MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539000657 ()
  • 03664539003276 ()

  • Length: 20 Millimeter
ACS-020SMS-10

  • Depth electrode
SET OF 10 ANCHOR BOLTS, LENGTH 15MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539000640 ()
  • 03664539003269 ()

  • Length: 15 Millimeter
ACS-015SMS-10

  • Depth electrode
SET OF 10 STYLETS, Ø 0.8MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
STYLET
In Commercial Distribution

  • 03664539000572 ()
  • 03664539003191 ()

  • Outer Diameter: 0.8 Millimeter
ACS-770S-10

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539000466 ()
ACS-789-ROSA

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539000459 ()
ACS-789/120

  • Depth electrode
GUIDE FOR Ø 2.45MM ACCESSORIES, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539000435 ()
ACS-1300

  • Depth electrode
SEEG DEPTH ELECTRODE, 18 CONTACTS, EXPLORATION LENGTH 61.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000183 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-18AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 18 CONTACTS, EXPLORATION LENGTH 61.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000176 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-18AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 62MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000169 ()

  • Special Insulating Length between groups of 5 contacts 7 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15BT

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 62MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000152 ()

  • Special Insulating Length between groups of 5 contacts 7 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15BM

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x6 CONTACTS, EXPLORATION LENGTH 80.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000145 ()

  • Special Insulating Length between groups of 6 contacts 11 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-18CT

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x6 CONTACTS, EXPLORATION LENGTH 80.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000138 ()

  • Special Insulating Length between groups of 6 contacts 11 Millimeters
  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-18CM

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 70MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000121 ()

  • Special Insulating Length between groups of 5 contacts 11 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15CT

  • Depth electrode
SEEG DEPTH ELECTRODE, 3x5 CONTACTS, EXPLORATION LENGTH 70MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000114 ()

  • Special Insulating Length between groups of 5 contacts 11 Millimeters
  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15CM

  • Depth electrode
SEEG DEPTH ELECTRODE, 15 CONTACTS, EXPLORATION LENGTH 51MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000107 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-15AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 15 CONTACTS, EXPLORATION LENGTH 51MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000091 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-15AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 12 CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000084 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-12AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 12 CONTACTS, EXPLORATION LENGTH 40.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000077 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-12AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 10 CONTACTS, EXPLORATION LENGTH 33.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000060 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-10AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 10 CONTACTS, EXPLORATION LENGTH 33.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000053 ()

  • Contact Length 2 Millimeters
  • Contact Spacing 3.5 Millimeters
D08-10AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 8 CONTACTS, EXPLORATION LENGTH 26.5MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000046 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-08AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 8 CONTACTS, EXPLORATION LENGTH 26.5MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000039 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-08AM

  • Depth electrode
SEEG DEPTH ELECTRODE, 5 CONTACTS, EXPLORATION LENGTH 16MM, Ø 0.8MM, SHORT LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
Not in Commercial Distribution

  • 03664539000022 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-05AT

  • Depth electrode
SEEG DEPTH ELECTRODE, 5 CONTACTS, EXPLORATION LENGTH 16MM, Ø 0.8MM, LONG LENGTH
DIXI MEDICAL
MICRODEEP DEPTH ELECTRODE
In Commercial Distribution

  • 03664539000015 ()

  • Contact Spacing 3.5 Millimeters
  • Contact Length 2 Millimeters
D08-05AM

  • Depth electrode
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
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
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
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
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
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
Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable
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
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
ICM-000-0422
I.C. MEDICAL, INC.
2250J
Not in Commercial Distribution

2250J

  • Surgical plume evacuation system
ICM-000-0420
I.C. MEDICAL, INC.
2210J
Not in Commercial Distribution

  • 00817688022350 ()
  • 00817688022343 ()
  • 00817688021476 ()
2210J

  • Surgical plume evacuation system
ULPA/CHARCOAL FILTER CATRIDGES
Conmed Corporation
60-5902-001
Not in Commercial Distribution

  • 20848584045456 ()
  • 10848584045459 ()
  • 00848584045452 ()
60-5902-001

  • Surgical plume evacuation system
No Description
NORTHGATE TECHNOLOGIES INC.
7-700-00
In Commercial Distribution

  • 00817183020684 ()


  • Surgical plume evacuation system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00840682140829 ()


  • Stationary gamma camera system
830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00195278788252 ()
5376204-33

  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
870CZT
In Commercial Distribution

  • 00840682140843 ()


  • Full-body CT system
  • Stationary gamma camera system
870 DR NM GANTRY FINAL - NEW ROTOR
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00840682140836 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
850
In Commercial Distribution

  • 00840682140775 ()


  • Full-body CT system
  • Stationary gamma camera system
NM CT 860 Gantry Final
G E MEDICAL SYSTEMS ISRAEL LTD.
860
In Commercial Distribution

  • 00840682140751 ()


  • Full-body CT system
  • Stationary gamma camera system
870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
G E MEDICAL SYSTEMS ISRAEL LTD.
870 DR
In Commercial Distribution

  • 00195278788269 ()


  • Stationary gamma camera system
  • Full-body CT system
SafeAir Compact Smoke Evacuator
STRYKER CORPORATION
0703-045-000
In Commercial Distribution

  • 07613327466249 ()
0703-045-000

  • Surgical plume evacuation system
7 m Extension Tubing
STRYKER CORPORATION
0703-045-003
In Commercial Distribution

  • 07613327504125 ()
0703-045-003

  • Surgical plume evacuation system
Grounding Cable
STRYKER CORPORATION
0703-045-002
In Commercial Distribution

  • 07613327504118 ()
0703-045-002

  • Surgical plume evacuation system
No Description
Synapse Biomedical, Inc.
20-0036
In Commercial Distribution

  • 00852184003045 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0046
In Commercial Distribution

  • 00852184003052 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
20-0028
In Commercial Distribution

  • 00852184003038 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
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