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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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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

LEG-UP - 05050962080065

LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP YELLOW 26IN
In Commercial Distribution

  • 05050962080065 ()
HA0965

  • Movement-resistance gait rehabilitation device

LEG-UP - 05050962023048

LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP BLACK 26IN
In Commercial Distribution

  • 05050962023048 ()
HA0970

  • Movement-resistance gait rehabilitation device

THIN GAIT BELT 54 INCH 20/CA - 00733657286090

No Description
ALIMED, INC.
71243720
In Commercial Distribution

  • 00733657286090 ()
  • 00733657300321 ()
2970008985

  • Movement-resistance gait rehabilitation device

BELT WALKER PEDIATRIC (10) - 00733657284690

No Description
ALIMED, INC.
3123
In Commercial Distribution

  • 00733657284690 ()
2970000595

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 70IN W/ PLASTIC BUCKLE YELLOW - 00733657274523

No Description
ALIMED, INC.
713584
In Commercial Distribution

  • 00733657274523 ()
2970009328

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54IN W/ PLASTIC BUCKLE YELLOW - 00733657274516

No Description
ALIMED, INC.
713583
In Commercial Distribution

  • 00733657274516 ()
2970009326

  • Movement-resistance gait rehabilitation device

BELT GAIT WITH ODOR CONTROL 54IN 20/CS - 00733657242645

No Description
ALIMED, INC.
7025720
In Commercial Distribution

  • 00733657242645 ()
  • 00733657299533 ()
2970008131

  • Movement-resistance gait rehabilitation device

THIN GAIT BELT 54 INCH - 00733657232141

No Description
ALIMED, INC.
712437
In Commercial Distribution

  • 00733657232141 ()
2970008984

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 70 IN PLASTIC BUCKLE CS 36 - 00733657230635

No Description
ALIMED, INC.
710135
In Commercial Distribution

  • 00733657230635 ()
  • 00733657299281 ()
2970008478

  • Movement-resistance gait rehabilitation device

BLT GT DISP BL 70 IN MET BUK CS 36 - 00733657230604

No Description
ALIMED, INC.
710132
In Commercial Distribution

  • 00733657230604 ()
  • 00733657299274 ()
2970008477

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN PLASTIC BUCKLECS 100 - 00733657230598

No Description
ALIMED, INC.
710131
In Commercial Distribution

  • 00733657230598 ()
  • 00733657299267 ()
2970008476

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN PLASTIC BUCKLE CS 36 - 00733657230574

No Description
ALIMED, INC.
710129
In Commercial Distribution

  • 00733657230574 ()
  • 00733657299250 ()
2970008475

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN METAL BUCKLE CS 100 - 00733657230567

No Description
ALIMED, INC.
710128
In Commercial Distribution

  • 00733657230567 ()
  • 00733657299243 ()
2970008474

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN METAL BUCKLE CS 36 - 00733657230543

No Description
ALIMED, INC.
710126
In Commercial Distribution

  • 00733657230543 ()
  • 00733657299236 ()
2970008473

  • Movement-resistance gait rehabilitation device

BELT QC AMBULATION - 00733657229271

No Description
ALIMED, INC.
77905
In Commercial Distribution

  • 00733657229271 ()
2970010245

  • Movement-resistance gait rehabilitation device

GAIT BELT RED/WHIT/BLUE 70 INCH METAL BUCKLE - 00733657228823

No Description
ALIMED, INC.
77178
In Commercial Distribution

  • 00733657228823 ()
2970010129

  • Movement-resistance gait rehabilitation device

GAIT BELT RED/WHIT/BLUE 54 INCH METAL BUCKLE - 00733657228793

No Description
ALIMED, INC.
77175
In Commercial Distribution

  • 00733657228793 ()
2970010127

  • Movement-resistance gait rehabilitation device

GAIT BELT WITH ODOR CONTROL 54IN - 00733657227673

No Description
ALIMED, INC.
70257
In Commercial Distribution

  • 00733657227673 ()
2970008130

  • Movement-resistance gait rehabilitation device

GAIT BELT WITH ODOR CONTROL 70IN - 00733657227666

No Description
ALIMED, INC.
70256
In Commercial Distribution

  • 00733657227666 ()
2970008129

  • Movement-resistance gait rehabilitation device

BELT GAIT/TRANSFER PINSTRIPE 54IN - 00733657223996

No Description
ALIMED, INC.
7414
In Commercial Distribution

  • 00733657223996 ()
2970009877

  • Movement-resistance gait rehabilitation device

GAIT/TRANSFER BELT METAL BUCKLE PINSTRIPE 70IN - 00733657223897

No Description
ALIMED, INC.
7083
In Commercial Distribution

  • 00733657223897 ()
2970008349

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 96" W/ PLASTIC BUCKLE YELLOW - 00733657216172

No Description
ALIMED, INC.
711779
In Commercial Distribution

  • 00733657216172 ()
2970008801

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 70 INCH W/ PLASTIC BUCKLE BLUE - 00733657216141

No Description
ALIMED, INC.
711029
In Commercial Distribution

  • 00733657216141 ()
2970008697

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54 INCH W/ PLASTIC BUCKLE BLUE - 00733657216134

No Description
ALIMED, INC.
711026
In Commercial Distribution

  • 00733657216134 ()
2970008694

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 70 INCH W/ PLASTIC BUCKLE ORANGE - 00733657216127

No Description
ALIMED, INC.
711023
In Commercial Distribution

  • 00733657216127 ()
2970008693

  • Movement-resistance gait rehabilitation device

WIPEABLE GAIT BELT 54 INCH W/ PLASTIC BUCKLE ORANGE - 00733657216110

No Description
ALIMED, INC.
711020
In Commercial Distribution

  • 00733657216110 ()
2970008691

  • Movement-resistance gait rehabilitation device

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)

Malem - 05060049630199

Queen's Square Bladder Stimulator (PC9)
MALEM MEDICAL LIMITED
PC9
In Commercial Distribution

  • 05060049630199 ()


  • Bladder-emptying vibratory stimulator

Malem - 05060049630144

Queen's Square Bladder Stimulator - Selectable (PC9S)
MALEM MEDICAL LIMITED
PC9S
In Commercial Distribution

  • 05060049630144 ()


  • Bladder-emptying vibratory stimulator

Avery Breathing Pacemaker System - 00850252006066

Digital Transmitter for the Avery Breathing Pacemaker System
Avery Biomedical Devices Inc
NeurostimulatorTransmitter Digital
In Commercial Distribution

  • 00850252006066 ()
Spirit

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006059

No Description
Avery Biomedical Devices Inc
Transtelephonic Monitor
Not in Commercial Distribution

  • 00850252006059 ()
TTM

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006042

(902A) 2.0 m Lead Length
Avery Biomedical Devices Inc
External Antenna
In Commercial Distribution

  • 00850252006042 ()
902AL

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006035

(902A) 1.0 m Lead Length
Avery Biomedical Devices Inc
External Antenna
In Commercial Distribution

  • 00850252006035 ()
902A

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Avery Breathing Pacemaker System - 00850252006004

No Description
Avery Biomedical Devices Inc
Neurostimulator Transmitter
In Commercial Distribution

  • 00850252006004 ()
MARK IV

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

Origin Size 18 Template - 09348215074807

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-118
In Commercial Distribution

  • 09348215074807 ()


  • Surgical implant template, reusable

Origin Size 15 Template - 09348215074784

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-115
In Commercial Distribution

  • 09348215074784 ()


  • Surgical implant template, reusable

Origin Size 13 Template - 09348215074760

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-113
In Commercial Distribution

  • 09348215074760 ()


  • Surgical implant template, reusable

Origin Size 11 Template - 09348215074746

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-111
In Commercial Distribution

  • 09348215074746 ()


  • Surgical implant template, reusable
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