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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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Origin Instrument Tray - 09348215039882

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-001
In Commercial Distribution

  • 09348215039882 ()


  • Instrument tray, reusable

Origin Trial Neck - 09348215039813

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-022
In Commercial Distribution

  • 09348215039813 ()


  • Surgical implant template, reusable

Origin Trial Neck - 09348215039806

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-021
In Commercial Distribution

  • 09348215039806 ()


  • Surgical implant template, reusable

Origin Trial Neck - 09348215039790

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-020
In Commercial Distribution

  • 09348215039790 ()


  • Surgical implant template, reusable

Origin DAA Broach - 09348215080433

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3018
In Commercial Distribution

  • 09348215080433 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080419

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3015
In Commercial Distribution

  • 09348215080419 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080389

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3012
In Commercial Distribution

  • 09348215080389 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080372

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3011
In Commercial Distribution

  • 09348215080372 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080365

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3010
In Commercial Distribution

  • 09348215080365 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080358

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3009
In Commercial Distribution

  • 09348215080358 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080341

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3008
In Commercial Distribution

  • 09348215080341 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080426

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3016
In Commercial Distribution

  • 09348215080426 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080402

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3014
In Commercial Distribution

  • 09348215080402 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080396

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-3013
In Commercial Distribution

  • 09348215080396 ()


  • Orthopaedic broach

N/A - 00849044042283

Incision Locator
GLOBUS MEDICAL, INC.
675.404
In Commercial Distribution

  • 00849044042283 ()


  • Cardiovascular patch, animal-derived

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)

ZOLL-DENTAL - 00840105205647

Custom Finish (SP-XXXX)
Zoll-Dental
GP-SP
In Commercial Distribution

  • 00840105205647 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205623

6.0mm/8.0mm Smooth
Zoll-Dental
GP-6.0/8.0SM
In Commercial Distribution

  • 00840105205623 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205616

6.0mm/8.0mm Serrated
Zoll-Dental
GP-6.0/8.0SER
In Commercial Distribution

  • 00840105205616 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205609

5.0mm/5.5mm Smooth
Zoll-Dental
GP-5.0/5.5SM
In Commercial Distribution

  • 00840105205609 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205593

5.0mm/5.5mm Serrated
Zoll-Dental
GP-5.0/5.5SER
In Commercial Distribution

  • 00840105205593 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205586

4.2mm/4.8mm Smooth
Zoll-Dental
GP-4.2/4.8SM
In Commercial Distribution

  • 00840105205586 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205579

4.2mm/4.8mm Serrated
Zoll-Dental
GP-4.2/4.8SER
In Commercial Distribution

  • 00840105205579 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205562

3.2mm/3.8mm Smooth
Zoll-Dental
GP-3.2/3.8SM
In Commercial Distribution

  • 00840105205562 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205555

3.2mm/3.8mm Serrated
Zoll-Dental
GP-3.2/3.8SER
In Commercial Distribution

  • 00840105205555 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205548

1.8mm/2.8mm Smooth
Zoll-Dental
GP-1.8/2.8SM
In Commercial Distribution

  • 00840105205548 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205531

1.8mm/2.8mm Serrated
Zoll-Dental
GP-1.8/2.8SER
In Commercial Distribution

  • 00840105205531 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205524

1.5mm/1.8mm Smooth
Zoll-Dental
GP-1.5/1.8SM
In Commercial Distribution

  • 00840105205524 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105205517

1.5mm/1.8mm Serrated
Zoll-Dental
GP-1.5/1.8SER
In Commercial Distribution

  • 00840105205517 ()


  • Bone graft packing block

icotec Lumbar Cage, Implant Holder for Tamping - 07640164841830

icotec Lumbar Cage, Implant Holder for Tamping
icotec AG
38-036
In Commercial Distribution

  • 07640164841830 ()
38-036

  • Bone graft packing block

ENDOSKELETON® TCS - 00191375028345

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

ENDOSKELETON® TAS - 00191375028338

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

Unity - 08800039822183

SIJ Bone Graft Packing Instrument
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039822183 ()
SI.IN.0031

  • Bone graft packing block

NA - 08800042415952

Platform
Medyssey Co., Ltd.
NAPF-001
In Commercial Distribution

  • 08800042415952 ()


  • Bone graft packing block

Velofix™ PEEK Lumbar Cage - 08800015954730

No Description
Innosys Co., Ltd.
PL0450
In Commercial Distribution

  • 08800015954730 ()


  • Bone graft packing block

VELOFIX™ PEEK CERVICAL CAGE - 08800015953986

No Description
Innosys Co., Ltd.
PE1020
In Commercial Distribution

  • 08800015953986 ()


  • Bone graft packing block

Global Spinal Fixation System™ - 08800015946414

No Description
Innosys Co., Ltd.
SG0019
In Commercial Distribution

  • 08800015946414 ()


  • Bone graft packing block

Velofix™ TLIF Cage - 08800015995474

No Description
Innosys Co., Ltd.
TL0520
In Commercial Distribution

  • 08800015995474 ()


  • Bone graft packing block

EVOL®ha-C Cervical Interbody System - 00841193121246

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

PERLA ® TL MIS - 07640450867872

MODULAR SCREW BASE
SpineArt SA
MPF-IN 33 00-N
In Commercial Distribution

  • 07640450867872 ()
MPF-IN 33 00-N

  • Bone graft packing block

TRYPTIK ® TI - 07640450863478

COMPACTION BASE
SpineArt SA
TRY-IN 53 00 -N
In Commercial Distribution

  • 07640450863478 ()
TRY-IN 53 00 -N

  • Bone graft packing block

TRYPTIK ® TI - 07640450863461

COMPACTOR
SpineArt SA
TRY-IN 52 00-N
In Commercial Distribution

  • 07640450863461 ()
TRY-IN 52 00-N

  • Bone graft packing block

ZOLL DENTAL - 00840105222132

Moody 5.0mm
Zoll-Dental
GP-Moody-5.0
In Commercial Distribution

  • 00840105222132 ()


  • Bone graft packing block

ZOLL DENTAL - 00840105222125

Moody 4.0mm
Zoll-Dental
GP-Moody-4.0
In Commercial Distribution

  • 00840105222125 ()


  • Bone graft packing block

ZOLL DENTAL - 00840105222118

Moody 3.0mm
Zoll-Dental
GP-Moody-3.0
In Commercial Distribution

  • 00840105222118 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105220503

Graft Packer/Plugger
Zoll-Dental
Z-7223
In Commercial Distribution

  • 00840105220503 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105220497

Graft Packer/Plugger
Zoll-Dental
Z-7222
In Commercial Distribution

  • 00840105220497 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105220480

Graft Packer/Plugger
Zoll-Dental
Z-7221
In Commercial Distribution

  • 00840105220480 ()


  • Bone graft packing block

ZOLL-DENTAL - 00840105220473

Graft Packer/Plugger
Zoll-Dental
Z-7220
In Commercial Distribution

  • 00840105220473 ()


  • Bone graft packing block
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