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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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Ultracell® - 30886158012253

***NON-STERILE*** SINUS PACK W/STRING- 3.5CM X 1.2CM X 1.2CM (1000/SP)
Beaver-Visitec International, Inc.
NS20210-C
In Commercial Distribution

  • 30886158012253 ()
NS20210-C

  • ENT space-occupying dressing, human-derived

Ultracell® - 30886158012246

***NON-STERILE*** CLASSIC NASAL PACK W/TUBE , 4.5CM W/STRING, NO VAC FOIL (500/SP)
Beaver-Visitec International, Inc.
NS10100-CTN
In Commercial Distribution

  • 30886158012246 ()
NS10100-CTN

  • ENT space-occupying dressing, human-derived

Ultracell® - 30886158012239

***NON-STERILE*** CLASSIC NASAL PACK, 8 CM W/STRING (500/SP)
Beaver-Visitec International, Inc.
NS10110-C
In Commercial Distribution

  • 30886158012239 ()
NS10110-C

  • ENT space-occupying dressing, human-derived

Ultracell® - 30886158012222

***NON-STERILE*** CLASSIC NASAL PACK W/TUBE, 8 CM W/STRING, NO VAC FOIL (500/SP)
Beaver-Visitec International, Inc.
NS10110-CTN
In Commercial Distribution

  • 30886158012222 ()
NS10110-CTN

  • ENT space-occupying dressing, human-derived

Origin DAA Broach - 09348215080419

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

  • 09348215080419 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080396

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

  • 09348215080396 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080365

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

  • 09348215080365 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080341

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

  • 09348215080341 ()


  • Orthopaedic broach

Origin DAA Broach - 09348215080433

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

  • 09348215080433 ()


  • 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 - 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 - 09348215080358

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

  • 09348215080358 ()


  • Orthopaedic broach

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

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
Not in Commercial Distribution

  • 20816101025521 ()


  • Influenza A virus H1N1 subtype (swine influenza) nucleic acid IVD, kit, nucleic acid technique (NAT)

N/A - 00849044042283

Incision Locator
GLOBUS MEDICAL, INC.
675.404
In Commercial Distribution

  • 00849044042283 ()


  • Cardiovascular patch, animal-derived

Unity - 08800039822183

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

  • 08800039822183 ()
SI.IN.0031

  • Bone graft packing block

CxHA™ - M711LS4590

Polypropylene
Innovasis, Inc.
LS-459
In Commercial Distribution

  • M711LS4590 ()
LS-459

  • Bone graft packing block

NA - 08800042415952

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

  • 08800042415952 ()


  • Bone graft packing block

A-Box® - M711LAA0400

Bone Graft Block Assembly, Al, SST
Innovasis, Inc.
LAA-040
In Commercial Distribution

  • M711LAA0400 ()


  • Bone graft packing block

NA - 08800048410296

TLIF Bone Packing Block
Medyssey Co., Ltd.
NTPB-001
In Commercial Distribution

  • 08800048410296 ()


  • Bone graft packing block

NA - 08800048404127

Packing Block(C7)
Medyssey Co., Ltd.
N7PB-001
In Commercial Distribution

  • 08800048404127 ()


  • Bone graft packing block

NA - 08800048402215

Platform - W11 (Dynamic/Varian&EP)
Medyssey Co., Ltd.
NDPF-001
In Commercial Distribution

  • 08800048402215 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223123

Bone Condenser 8/9
BLUE SKY BIO LLC
STPCND89
In Commercial Distribution

  • 00810060223123 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223109

Bone Condenser 6/7
BLUE SKY BIO LLC
STPCND67
In Commercial Distribution

  • 00810060223109 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223093

Bone Condenser 4/5
BLUE SKY BIO LLC
STPCND45
In Commercial Distribution

  • 00810060223093 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223086

Bone Condenser 2/3
BLUE SKY BIO LLC
STPCND23
In Commercial Distribution

  • 00810060223086 ()


  • Bone graft packing block

SRH3427LBlue Sky Bio, LLC - 00810060223079

Bone Condenser 10/11
BLUE SKY BIO LLC
STPCND1011
In Commercial Distribution

  • 00810060223079 ()


  • Bone graft packing block

PERLA TL - 07640375236173

CURVED TAMP
SpineArt SA
SPE-US 01 42-N
In Commercial Distribution

  • 07640375236173 ()
SPE-US 01 42-N

  • Bone graft packing block

SCARLET® AC-Ti - 07640332478455

COMPACTION BASE
SpineArt SA
SCA-IC 17 00-N
In Commercial Distribution

  • 07640332478455 ()
SCA-IC 17 00-N

  • 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

JULIET ® INSTRUMENTATION - 07640178983052

ANGULATED IMPACTOR
SpineArt SA
JLL-IN 11 02-N
Not in Commercial Distribution

  • 07640178983052 ()
JLL-IN 11 02-N

  • Bone graft packing block

JULIET ® INSTRUMENTATION - 07640178982819

STRAIGHT IMPACTOR
SpineArt SA
JLL-IN 11 01-N
Not in Commercial Distribution

  • 07640178982819 ()
JLL-IN 11 01-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640178982765

COMPACTION BASE
SpineArt SA
JLL-IN 08 01-N
In Commercial Distribution

  • 07640178982765 ()
JLL-IN 08 01-N

  • Bone graft packing block

JULIET ® INSTRUMENTATION - 07640178981638

COMPACTION BASE
SpineArt SA
JUT-IN 00 01-N
Not in Commercial Distribution

  • 07640178981638 ()
JUT-IN 00 01-N

  • Bone graft packing block

JULIET ® Ti LL Instrumentation - 07640185342989

Base
SpineArt SA
JLL-IN 44 00-N
In Commercial Distribution

  • 07640185342989 ()
JLL-IN 44 00-N

  • Bone graft packing block

SCARLET AL-T INSTRUMENTATION - 07640185340862

COMPACTOR
SpineArt SA
SCA-IN 19 00-N
In Commercial Distribution

  • 07640185340862 ()
SCA-IN 19 00-N

  • Bone graft packing block

SCARLET AL-T INSTRUMENTATION - 07640185340015

COMPACTION BASE
SpineArt SA
SCA-IN 07 00-N
In Commercial Distribution

  • 07640185340015 ()
SCA-IN 07 00-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139342881

Compaction base
SpineArt SA
DYN-IT 00 03-N
In Commercial Distribution

  • 07640139342881 ()
DYN-IT 00 03-N

  • Bone graft packing block

JULIET INSTRUMENTATION - 07640139342423

Compaction base
SpineArt SA
DYN-IP 00 03-N
In Commercial Distribution

  • 07640139342423 ()
DYN-IP 00 03-N

  • Bone graft packing block

Medtronic Reusable Instruments - 00763000056223

STATION EX0717016 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0717016
In Commercial Distribution

  • 00763000056223 ()


  • Bone graft packing block

n/a - 00763000216948

PACKING STATION EX0818003 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0818003
In Commercial Distribution

  • 00763000216948 ()


  • Bone graft packing block

Anteralign Spinal System with Titan nanoLock Surface technology - 00763000194000

BLOCK 4680011 LOADING BLOCK
MEDTRONIC SOFAMOR DANEK, INC.
4680011
In Commercial Distribution

  • 00763000194000 ()


  • Bone graft packing block
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