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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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Prometra II Pump - 00810335020228

The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution

  • 00810335020228 ()


  • Implantable intrathecal infusion pump, programmable

Prometra Programmable Pump - 00810335020082

The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable

PRIMO - 00840216117952

60" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB60MBNB
In Commercial Distribution

  • 00840216117952 ()


  • Gait rehabilitation system harness

PRIMO - 00840216117945

60" Gait Belt, Metal Buckle, Natural
Asp Global, LLC
GB60MBN
In Commercial Distribution

  • 00840216117945 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114067

72" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB72QRP
In Commercial Distribution

  • 00840216114067 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114050

72" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB72QRNRB
In Commercial Distribution

  • 00840216114050 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114043

72" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB72QRNB
In Commercial Distribution

  • 00840216114043 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114029

72" Gait Belt, Metal Buckle, Pastel
Asp Global, LLC
GB72MBP
In Commercial Distribution

  • 00840216114029 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114012

72" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB72MBNB
In Commercial Distribution

  • 00840216114012 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114005

60" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB60QRP
In Commercial Distribution

  • 00840216114005 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113992

60" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB60QRNB
In Commercial Distribution

  • 00840216113992 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113985

60" Gait Belt, Quick Release Buckle, Natural
Asp Global, LLC
GB60QRN
In Commercial Distribution

  • 00840216113985 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113978

60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107052

BELT, QUICK CLEAN GAIT, PINK, 36", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM36PK
In Commercial Distribution

  • 00840216107052 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107045

BELT, QUICK CLEAN GAIT, BLUE, 60", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM60BL
In Commercial Distribution

  • 00840216107045 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107038

BELT, QUICK CLEAN GAIT, BLACK, 72", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM72BK
In Commercial Distribution

  • 00840216107038 ()


  • Gait rehabilitation system harness

PRIMO - 00840216105737

BELT GAIT NATURAL STRIPES WITH BLUE & RED 54"
Asp Global, LLC
GBANS54
In Commercial Distribution

  • 00840216105737 ()


  • Gait rehabilitation system harness

PRIMO/ASP MEDICAL - 00840216100138

72" GAIT BELT - NATURAL, 1/EA
Asp Global, LLC
GB72MBN
In Commercial Distribution

  • 00840216100138 ()


  • Gait rehabilitation system harness

NA - 03664539003917

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

  • 03664539003917 ()
ACS-789/120R

  • Depth electrode

NA - 03664539003894

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 50, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003894 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B51P12

  • Depth electrode

NA - 03664539003870

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 34, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003870 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B33P12

  • Depth electrode

NA - 03664539003672

"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 5MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003726 ()
  • 03664539003672 ()

  • Length 40 Millimeters Length of the self-tapping thread 5 Millimeters
ACS-040SMS-10

  • Depth electrode

NA - 03664539003658

"SET OF 10 ANCHOR BOLTS, LENGTH 30MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003702 ()
  • 03664539003658 ()

  • Length 30 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-130SMS-10

  • Depth electrode

NA - 03664539003641

SET OF 10 ANCHOR BOLTS, LENGTH 25MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003696 ()
  • 03664539003641 ()

  • Length 25 Millimeters Length of the self-tapping part 10 Millimeters
ACS-125SMS-10

  • Depth electrode

NA - 03664539003535

TWIST DRILL FOR ANCHOR BOLT, LENGTH 250MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
In Commercial Distribution

  • 03664539003535 ()
KIP-ACS-515B

  • Depth electrode

NA - 03664539003467

SEEG DEPTH ELECTRODE, 9 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 40,8, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003467 ()

  • " Macro Contact Length 2 Millimeters Macro Contact Spacing 4,1 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-09A51D08

  • Depth electrode

NA - 03664539003429

SEEG DEPTH ELECTRODE, 9 MACRO AND 8 MICRO-CONTACTS, EXPLORATION LENGTH 33,2, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO-MACRO ELECTRODE
In Commercial Distribution

  • 03664539003429 ()

  • "Macro Contact Length 2 Millimeters Macro Contact Spacing 1,9 Millimeters Micro Contact Exposure Diameter 0,02 Millimeters"
MM08-09A33D08

  • Depth electrode

NA - 03664539002927

COAGULATION ELECTRODE FOR SCALP, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
COAGULATION ELECTRODE AND STOP
In Commercial Distribution

  • 03664539002927 ()
KIP-ACS-605

  • Depth electrode

NA - 03664539002811

TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 160MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002811 ()
KIP-ACS-519

  • Depth electrode

NA - 03664539002798

TWIST DRILL FOR ANCHOR BOLT, QUICK LOCKING SHANK, LENGTH 192MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002798 ()
KIP-ACS-517

  • Depth electrode

NA - 03664539002774

TWIST DRILL FOR ANCHOR BOLT, LENGTH 200MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
In Commercial Distribution

  • 03664539002774 ()
KIP-ACS-515

  • Depth electrode

NA - 03664539002729

TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 125MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002729 ()
KIP-ACS-512

  • Depth electrode

NA - 03664539002699

TWIST DRILL FOR ANCHOR BOLT, LENGTH 140MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
In Commercial Distribution

  • 03664539002699 ()
KIP-ACS-510

  • Depth electrode

NA - 03664539002422

8 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002422 ()
ADP-08

  • Depth electrode

NA - 03664539002408

12 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002408 ()
ADP-12

  • Depth electrode

NA - 03664539002279

LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
Not in Commercial Distribution

  • 03664539002279 ()

  • Length: 300 Centimeter
PCP-18A/300

  • Depth electrode

NA - 03664539002231

LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
In Commercial Distribution

  • 03664539002231 ()

  • Length: 300 Centimeter
PCP-18/300

  • Depth electrode

NA - 03664539002156

18 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002156 ()

  • Length: 120 Centimeter
CBL-18/120

  • Depth electrode

NA - 03664539001999

15 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001999 ()

  • Length: 300 Centimeter
CBL-15/300

  • Depth electrode

NA - 03664539001975

15 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001975 ()

  • Length: 150 Centimeter
CBL-15/150

  • Depth electrode

NA - 03664539001920

15 CONTACTS, LENGTH 30CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
Not in Commercial Distribution

  • 03664539001920 ()

  • Length: 30 Centimeter
CBL-15/30

  • Depth electrode

NA - 03664539001821

12 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001821 ()

  • Length: 180 Centimeter
CBL-12/180

  • Depth electrode

NA - 03664539001807

12 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001807 ()

  • Length: 120 Centimeter
CBL-12/120

  • Depth electrode

NA - 03664539001746

10 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001746 ()

  • Length: 180 Centimeter
CBL-10/180

  • Depth electrode

NA - 03664539001722

10 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001722 ()

  • Length: 120 Centimeter
CBL-10/120

  • Depth electrode

NA - 03664539001593

8 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001593 ()

  • Length: 300 Centimeter
CBL-08/300

  • Depth electrode

NA - 03664539001579

8 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001579 ()

  • Length: 150 Centimeter
CBL-08/150

  • Depth electrode

NA - 03664539001524

8 CONTACTS, LENGTH 30CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
Not in Commercial Distribution

  • 03664539001524 ()

  • Length: 30 Centimeter
CBL-08/30

  • Depth electrode

NA - 03664539001463

5 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001463 ()

  • Length: 180 Centimeter
CBL-05/180

  • Depth electrode

NA - 03664539001449

5 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001449 ()

  • Length: 120 Centimeter
CBL-05/120

  • Depth electrode
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