Company Name Brand Name GMDN Term FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Class Implantable

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ELVIS MWP W24/24F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2424S
In Commercial Distribution

  • 30014613333098 ()
55-2424S

  • Cell culture line IVD
ELVIS MWP W24/24F
DIAGNOSTIC HYBRIDS, INC.
55-2424
In Commercial Distribution

  • 30014613333081 ()
55-2424

  • Cell culture line IVD
ELVIS MWP W24/18F WITH CS
DIAGNOSTIC HYBRIDS, INC.
55-2418S
In Commercial Distribution

  • 30014613333074 ()
55-2418S

  • Cell culture line IVD
ELVIS MWP W24/18F
DIAGNOSTIC HYBRIDS, INC.
55-2418
In Commercial Distribution

  • 30014613333067 ()
55-2418

  • Cell culture line IVD
ELVIS MWP W24/12F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2412S
In Commercial Distribution

  • 30014613333050 ()
55-2412S

  • Cell culture line IVD
ELVIS MWP W24/12F
DIAGNOSTIC HYBRIDS, INC.
55-2412
In Commercial Distribution

  • 30014613333043 ()
55-2412

  • Cell culture line IVD
ELVIS MWP W24/10F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2410S
In Commercial Distribution

  • 30014613333036 ()
55-2410S

  • Cell culture line IVD
ELVIS MWP W24/9F
DIAGNOSTIC HYBRIDS, INC.
55-2409
In Commercial Distribution

  • 30014613333029 ()
55-2409

  • Cell culture line IVD
ELVIS MWP W24/8F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
55-2408DF
In Commercial Distribution

  • 30014613333012 ()
55-2408DF

  • Cell culture line IVD
ELVIS MWP W24/8F CUST
DIAGNOSTIC HYBRIDS, INC.
55-2408CB
In Commercial Distribution

  • 30014613333005 ()
55-2408CB

  • Cell culture line IVD
ELVIS MWP W24/6F W/CS
DIAGNOSTIC HYBRIDS, INC.
55-2406S
In Commercial Distribution

  • 30014613332992 ()
55-2406S

  • Cell culture line IVD
ELVIS MWP W24/6F CUST FILL
DIAGNOSTIC HYBRIDS, INC.
55-2406DE
In Commercial Distribution

  • 30014613332985 ()
55-2406DE

  • Cell culture line IVD
ELVIS MWP W24/6F
DIAGNOSTIC HYBRIDS, INC.
55-2406
In Commercial Distribution

  • 30014613332978 ()
55-2406

  • Cell culture line IVD
ELVIS SV/CS
DIAGNOSTIC HYBRIDS, INC.
55-0102
In Commercial Distribution

  • 30014613332961 ()
55-0102

  • Cell culture line IVD
ELVIS SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
55-0101
In Commercial Distribution

  • 30014613332954 ()
55-0101

  • Cell culture line IVD
Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007702
In Commercial Distribution

  • 10888234000853 ()
0007702

  • Immunoglobulin removal reagent IVD
Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 activity in serum or plasma. Gamma P1 Blood Group Substance is a standardized solution of avian P1 blood group substance in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007700
In Commercial Distribution

  • 10888234000846 ()
0007700

  • Immunoglobulin removal reagent IVD
No Description
DIASORIN MOLECULAR LLC
MOL2500
In Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
JBAIDS IVD Influenza A Subtyping Kit
BIOFIRE DEFENSE, LLC
JRPD-ASY-0138
Not in Commercial Distribution

  • 00851458005075 ()
JRPD-ASY-0138

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
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
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
In Commercial Distribution

  • 03664539002279 ()

  • Length: 300 Centimeter
PCP-18A/300

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

  • 03664539001920 ()

  • Length: 30 Centimeter
CBL-15/30

  • Depth electrode
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