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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No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 14
In Commercial Distribution

  • 08177570205028 ()
PR111-18-1403

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 13
In Commercial Distribution

  • 08177570205011 ()
PR111-18-1303

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 12
In Commercial Distribution

  • 08177570205004 ()
PR111-18-1203

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 11
In Commercial Distribution

  • 08177570204991 ()
PR111-18-1103

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 10
In Commercial Distribution

  • 08177570204984 ()
PR111-18-1003

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 9
In Commercial Distribution

  • 08177570204977 ()
PR111-18-0903

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 8
In Commercial Distribution

  • 08177570204960 ()
PR111-18-0803

  • Coated femoral stem prosthesis, modular
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
Origin Stem, Coxa Vara Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1804
In Commercial Distribution

  • 08177570200696 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1604
In Commercial Distribution

  • 08177570200658 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1504
In Commercial Distribution

  • 08177570200610 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1404
In Commercial Distribution

  • 08177570200573 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1304
In Commercial Distribution

  • 08177570200535 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1204
In Commercial Distribution

  • 08177570200498 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1104
In Commercial Distribution

  • 08177570200450 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 10
PAXEON RECONSTRUCTION LLC
PR111-18-1004
In Commercial Distribution

  • 08177570200412 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Coxa Vara Size 9
PAXEON RECONSTRUCTION LLC
PR111-18-0904
In Commercial Distribution

  • 08177570200375 ()


  • Coated hip femur prosthesis, modular
Eye Level Digital Scale, Origin USA
Pelstar, LLC
501KL
In Commercial Distribution

  • 00851628008066 ()


  • Stand-on floor scale, electronic
No Description
ALIMED, INC.
71243720
In Commercial Distribution

  • 00733657286090 ()
  • 00733657300321 ()
2970008985

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
3123
In Commercial Distribution

  • 00733657284690 ()
2970000595

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
713584
In Commercial Distribution

  • 00733657274523 ()
2970009328

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
712437
In Commercial Distribution

  • 00733657232141 ()
2970008984

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710135
In Commercial Distribution

  • 00733657230635 ()
  • 00733657299281 ()
2970008478

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710132
In Commercial Distribution

  • 00733657230604 ()
  • 00733657299274 ()
2970008477

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710131
In Commercial Distribution

  • 00733657230598 ()
  • 00733657299267 ()
2970008476

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710129
In Commercial Distribution

  • 00733657230574 ()
  • 00733657299250 ()
2970008475

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710128
In Commercial Distribution

  • 00733657230567 ()
  • 00733657299243 ()
2970008474

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710126
In Commercial Distribution

  • 00733657230543 ()
  • 00733657299236 ()
2970008473

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
77905
In Commercial Distribution

  • 00733657229271 ()
2970010245

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
77178
In Commercial Distribution

  • 00733657228823 ()
2970010129

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
77175
In Commercial Distribution

  • 00733657228793 ()
2970010127

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
70257
In Commercial Distribution

  • 00733657227673 ()
2970008130

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
70256
In Commercial Distribution

  • 00733657227666 ()
2970008129

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
7414
In Commercial Distribution

  • 00733657223996 ()
2970009877

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
7083
In Commercial Distribution

  • 00733657223897 ()
2970008349

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711779
In Commercial Distribution

  • 00733657216172 ()
2970008801

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711029
In Commercial Distribution

  • 00733657216141 ()
2970008697

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711026
In Commercial Distribution

  • 00733657216134 ()
2970008694

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711023
In Commercial Distribution

  • 00733657216127 ()
2970008693

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
711020
In Commercial Distribution

  • 00733657216110 ()
2970008691

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
7025720
In Commercial Distribution

  • 00733657242645 ()
  • 00733657299533 ()
2970008131

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
713583
In Commercial Distribution

  • 00733657274516 ()
2970009326

  • Movement-resistance gait rehabilitation device
LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP YELLOW 26IN
In Commercial Distribution

  • 05050962080065 ()
HA0965

  • Movement-resistance gait rehabilitation device
LEG-UP
THE HELPING HAND COMPANY (LEDBURY) LIMITED
LEG-UP BLACK 26IN
In Commercial Distribution

  • 05050962023048 ()
HA0970

  • Movement-resistance gait rehabilitation device
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)
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)
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0406
In Commercial Distribution

  • 00085412818696 ()
SPG0406

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0404
In Commercial Distribution

  • 00085412818672 ()
SPG0404

  • Cardiovascular patch, animal-derived
PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG1225
In Commercial Distribution

  • 00085412818658 ()
PG1225

  • Cardiovascular patch, animal-derived
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