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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 - 30014613333098

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

  • 30014613333098 ()
55-2424S

  • Cell culture line IVD

ELVIS - 30014613333081

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

  • 30014613333081 ()
55-2424

  • Cell culture line IVD

ELVIS - 30014613333074

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

  • 30014613333074 ()
55-2418S

  • Cell culture line IVD

ELVIS - 30014613333067

ELVIS MWP W24/18F
DIAGNOSTIC HYBRIDS, INC.
55-2418
In Commercial Distribution

  • 30014613333067 ()
55-2418

  • Cell culture line IVD

ELVIS - 30014613333050

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

  • 30014613333050 ()
55-2412S

  • Cell culture line IVD

ELVIS - 30014613333043

ELVIS MWP W24/12F
DIAGNOSTIC HYBRIDS, INC.
55-2412
In Commercial Distribution

  • 30014613333043 ()
55-2412

  • Cell culture line IVD

ELVIS - 30014613333036

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

  • 30014613333036 ()
55-2410S

  • Cell culture line IVD

ELVIS - 30014613333029

ELVIS MWP W24/9F
DIAGNOSTIC HYBRIDS, INC.
55-2409
In Commercial Distribution

  • 30014613333029 ()
55-2409

  • Cell culture line IVD

ELVIS - 30014613333012

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

  • 30014613333012 ()
55-2408DF

  • Cell culture line IVD

ELVIS - 30014613333005

ELVIS MWP W24/8F CUST
DIAGNOSTIC HYBRIDS, INC.
55-2408CB
In Commercial Distribution

  • 30014613333005 ()
55-2408CB

  • Cell culture line IVD

ELVIS - 30014613332992

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

  • 30014613332992 ()
55-2406S

  • Cell culture line IVD

ELVIS - 30014613332985

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

  • 30014613332985 ()
55-2406DE

  • Cell culture line IVD

ELVIS - 30014613332978

ELVIS MWP W24/6F
DIAGNOSTIC HYBRIDS, INC.
55-2406
In Commercial Distribution

  • 30014613332978 ()
55-2406

  • Cell culture line IVD

ELVIS - 30014613332961

ELVIS SV/CS
DIAGNOSTIC HYBRIDS, INC.
55-0102
In Commercial Distribution

  • 30014613332961 ()
55-0102

  • Cell culture line IVD

ELVIS - 30014613332954

ELVIS SV WITHOUT CS
DIAGNOSTIC HYBRIDS, INC.
55-0101
In Commercial Distribution

  • 30014613332954 ()
55-0101

  • Cell culture line IVD

Gamma Lewis Blood Group Substance - 10888234000853

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 - 10888234000846

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

JBAIDS - 00851458005075

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)

Simplexa™ Influenza A H1N1 (2009) - 20816101025521

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)

KEEOGO - CLINICIAN KIT - 07540162060007

Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

ReStore - 00860001744507

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

Atalante X - 03665965000129

The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
DMR-ATA-002.2
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical

Morning Walk - 08800043810121

No Description
CUREXO, Inc.
MW-V100
In Commercial Distribution

  • 08800043810121 ()


  • Treadmill/elliptical gait rehabilitation system

Morning Walk - 08800043810022

MW-S200
CUREXO, Inc.
MW-S200
In Commercial Distribution

  • 08800043810022 ()
AC-00000-000

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660254

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660254 ()
32001

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660247

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660247 ()
32000

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660223

No Description
HOCOMA AG
Nanos V1.2
In Commercial Distribution

  • 07640174660223 ()
31002

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660216

No Description
HOCOMA AG
Nanos V1.2
In Commercial Distribution

  • 07640174660216 ()
31001

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660209

No Description
HOCOMA AG
Nanos V1.2
In Commercial Distribution

  • 07640174660209 ()
31000

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660179

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660179 ()
30684

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660162

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660162 ()
30683

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660155

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660155 ()
30682

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660148

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660148 ()
30681

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660117

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660117 ()
30005

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660100

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660100 ()
30004

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660094

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660094 ()
30003

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660087

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660087 ()
30002

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660070

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660070 ()
30001

  • Treadmill/elliptical gait rehabilitation system

Lokomat - 07640174660063

No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660063 ()
30000

  • Treadmill/elliptical gait rehabilitation system
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