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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EKSO BIONICS SYSTEM, Ekso GT
EKSO BIONICS, INC.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

  • Programmable ambulation exoskeleton, clinical
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical
Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Medium Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft
5 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002446 ()
ADP-05

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

  • 03664539002422 ()
ADP-08

  • Depth electrode
10 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002415 ()
ADP-10

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

  • 03664539002408 ()
ADP-12

  • Depth electrode
15 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002392 ()
ADP-15

  • Depth electrode
18 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002385 ()
ADP-18

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

  • 03664539002279 ()

  • Length: 300 Centimeter
PCP-18A/300

  • Depth electrode
LENGTH 90CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
Not in Commercial Distribution

  • 03664539002262 ()

  • Length: 90 Centimeter
PCP-18A/90

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

  • 03664539002231 ()

  • Length: 300 Centimeter
PCP-18/300

  • Depth electrode
LENGTH 90CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
In Commercial Distribution

  • 03664539002217 ()

  • Length: 90 Centimeter
PCP-18/90

  • Depth electrode
18 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002187 ()

  • Length: 300 Centimeter
CBL-18/300

  • Depth electrode
18 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002170 ()

  • Length: 180 Centimeter
CBL-18/180

  • Depth electrode
18 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002163 ()

  • Length: 150 Centimeter
CBL-18/150

  • Depth electrode
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
18 CONTACTS, LENGTH 30CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
Not in Commercial Distribution

  • 03664539002118 ()

  • Length: 30 Centimeter
CBL-18/30

  • Depth electrode
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
15 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001982 ()

  • Length: 180 Centimeter
CBL-15/180

  • Depth electrode
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
15 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001968 ()

  • Length: 120 Centimeter
CBL-15/120

  • Depth electrode
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
12 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001838 ()

  • Length: 300 Centimeter
CBL-12/300

  • Depth electrode
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
12 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001814 ()

  • Length: 150 Centimeter
CBL-12/150

  • Depth electrode
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
12 CONTACTS, LENGTH 30CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
Not in Commercial Distribution

  • 03664539001760 ()

  • Length: 30 Centimeter
CBL-12/30

  • Depth electrode
10 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001753 ()

  • Length: 300 Centimeter
CBL-10/300

  • Depth electrode
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
10 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001739 ()

  • Length: 150 Centimeter
CBL-10/150

  • Depth electrode
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
10 CONTACTS, LENGTH 30CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
Not in Commercial Distribution

  • 03664539001685 ()

  • Length: 30 Centimeter
CBL-10/30

  • Depth electrode
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
8 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001586 ()

  • Length: 180 Centimeter
CBL-08/180

  • Depth electrode
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
8 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001562 ()

  • Length: 120 Centimeter
CBL-08/120

  • Depth electrode
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
5 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001470 ()

  • Length: 300 Centimeter
CBL-05/300

  • Depth electrode
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
5 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539001456 ()

  • Length: 150 Centimeter
CBL-05/150

  • Depth electrode
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