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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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
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-022
In Commercial Distribution

  • 09348215039813 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-021
In Commercial Distribution

  • 09348215039806 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-020
In Commercial Distribution

  • 09348215039790 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-001
In Commercial Distribution

  • 09348215039882 ()


  • Instrument tray, reusable
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
Not in Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)
Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block
Silverstone Graft Block
Altus Spine, LLC
780-0009
In Commercial Distribution

  • 00843210134079 ()


  • Bone graft packing block
EVOL®ha-C Cervical Bone Packing Block
Cutting Edge Spine, LLC
CES-472
In Commercial Distribution

  • 00841193121246 ()

  • Length: 50 Millimeter
CES-472

  • Bone graft packing block
Graft Packing & Screw Reference Block
TITAN SPINE, LLC
5210-1017
Not in Commercial Distribution

  • 00191375028345 ()

  • Height: 1 Inch
  • Width: 2 Inch
  • Length: 1.5 Inch
5210-1017

  • Bone graft packing block
Graft Packing & Screw Reference Block
TITAN SPINE, LLC
2300-1317
Not in Commercial Distribution

  • 00191375028338 ()

  • Width: 1.5 Inch
  • Length: 2 Inch
  • Height: 1.25 Inch
2300-1317

  • Bone graft packing block
Graft Packing Block
Life Spine, Inc.
113-774
In Commercial Distribution

  • 00190837066789 ()
113-774

  • Bone graft packing block
The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
MET 1 TECHNOLOGIES, LLC
04-07G
In Commercial Distribution

  • 00819824028691 ()
04-07G

  • Bone graft packing block
SIJ Bone Graft Packing Instrument
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039822183 ()
SI.IN.0031

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
SCA-IC 17 00-N
In Commercial Distribution

  • 07640332478455 ()
SCA-IC 17 00-N

  • Bone graft packing block
MODULAR SCREW BASE
SpineArt SA
MPF-IN 33 00-N
In Commercial Distribution

  • 07640450867872 ()
MPF-IN 33 00-N

  • Bone graft packing block
COMPACTION BASE
SpineArt SA
TRY-IN 53 00 -N
In Commercial Distribution

  • 07640450863478 ()
TRY-IN 53 00 -N

  • Bone graft packing block
COMPACTOR
SpineArt SA
TRY-IN 52 00-N
In Commercial Distribution

  • 07640450863461 ()
TRY-IN 52 00-N

  • Bone graft packing block
Compaction base
SpineArt SA
SCA-IC 04 00-N
In Commercial Distribution

  • 07640151086435 ()
SCA-IC 04 00-N

  • Bone graft packing block
Compactor
SpineArt SA
TRY-IN 01 00-N
In Commercial Distribution

  • 07640151081881 ()
TRY-IN 01 00-N

  • Bone graft packing block
Base
SpineArt SA
JLL-IN 44 00-N
In Commercial Distribution

  • 07640185342989 ()
JLL-IN 44 00-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IT 00 03-N
In Commercial Distribution

  • 07640139342881 ()
DYN-IT 00 03-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IP 00 03-N
In Commercial Distribution

  • 07640139342423 ()
DYN-IP 00 03-N

  • Bone graft packing block
Compactor
SpineArt SA
DYN-IP 00 02-N
In Commercial Distribution

  • 07640139342416 ()
DYN-IP 00 02-N

  • Bone graft packing block
Compaction base
SpineArt SA
DYN-IP 01 03-N
In Commercial Distribution

  • 07640139349941 ()
DYN-IP 01 03-N

  • Bone graft packing block
Compactor
SpineArt SA
PAD-IN 05 00-N
In Commercial Distribution

  • 07640139349309 ()
PAD-IN 05 00-N

  • Bone graft packing block
Compaction Base
SpineArt SA
PAD-IN 04 00-N
In Commercial Distribution

  • 07640139349293 ()
PAD-IN 04 00-N

  • Bone graft packing block
icotec Lumbar Cage, Implant Holder for Tamping
icotec AG
38-036
In Commercial Distribution

  • 07640164841830 ()
38-036

  • Bone graft packing block
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