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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FEM RESECTION GUIDE SCORPIO LRS INSTRUMENTATION
Howmedica Osteonics Corp.
8050-5109
In Commercial Distribution

  • 07613327239331 ()

  • Size: 9
8050-5109

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROXIMAL TIBIAL TEMPLATE SCORPIO IM REVISION SYSTEM
Howmedica Osteonics Corp.
8200-0009
In Commercial Distribution

  • 07613327234848 ()

  • Size: 9
8200-0009

  • Surgical implant template, reusable
XCELERATE UNIVERSAL BLOCK PEGLESS
Howmedica Osteonics Corp.
8000-3309
In Commercial Distribution

  • 07613327234626 ()

  • Size: 9
8000-3309

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PASSPORT AR KNEE INSTRUMENTATION AR FEMORAL RESECTION GUIDE
Howmedica Osteonics Corp.
7650-5109
In Commercial Distribution

  • 07613327234275 ()

  • Size: 9
7650-5109

  • Orthopaedic prosthesis implantation positioning instrument, reusable
UNIVERSAL NOTCH PREPARATION GUIDE
Howmedica Osteonics Corp.
7650-3369
In Commercial Distribution

  • 07613327233865 ()

  • Size: 9
7650-3369

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PASSPORT RESURFACING PATELLA SYSTEM PATELLA DRILL TEMPLATE
Howmedica Osteonics Corp.
7650-1709
In Commercial Distribution

  • 07613327233698 ()

  • Size: 9
7650-1709

  • Surgical drill guide, reusable
SERIES 7000 A/P SIZING GUIDE
Howmedica Osteonics Corp.
7502-0009
In Commercial Distribution

  • 07613327233070 ()

  • Size: 9
7502-0009

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SERIES 7000 CUTTING GUIDE
Howmedica Osteonics Corp.
7297-0009
In Commercial Distribution

  • 07613327232936 ()

  • Size: 9
7297-0009

  • Orthopaedic prosthesis implantation positioning instrument, reusable
TIBIAL PUNCH THRU BASEPLATE
Howmedica Osteonics Corp.
3750-0009-A
In Commercial Distribution

  • 07613327260205 ()

  • Size: 9
3750-0009-A

  • Surgical implant template, reusable
ACCOLADE II BROACH
Howmedica Osteonics Corp.
1020-5209
In Commercial Distribution

  • 07613327252606 ()

  • Size: 9
1020-5209

  • Orthopaedic broach
SCORPIO / NRG 4-IN-1 CUTTING BLOCK
Howmedica Osteonics Corp.
8010-2009
In Commercial Distribution

  • 07613327252347 ()

  • Size: 9
8010-2009

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 3 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-03-09
In Commercial Distribution

  • 00888118129161 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor
PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 6 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-06-09
In Commercial Distribution

  • 00888118129154 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor
PLATE, LEFORT 1, ADJ MIDFACE, BUTTRESS, CONE CONNECT, 5 MM AP, 9 MM BRG, TI-6AL-4V
KLS-Martin L.P.
51-401-09-09
In Commercial Distribution

  • 00888118129147 ()

  • 9 HOLE


  • Implantable craniofacial bone distractor
SECUR-FIT ADVANCED BROACH STRAIGHT
Howmedica Osteonics Corp.
1601-1009A
In Commercial Distribution

  • 07613327249880 ()

  • Size: 9
1601-1009A

  • Orthopaedic broach
Vessel Dilator 9 French
ARGON MEDICAL DEVICES, INC.
392309
In Commercial Distribution

  • 10886333210418 ()
  • 00886333210411 ()

  • 9 French
392309

  • Fascial tissue dilator, single-use
Vessel Dilator with Collar 9 French
ARGON MEDICAL DEVICES, INC.
392414
Not in Commercial Distribution

  • 10886333210555 ()
  • 00886333210558 ()

  • 9 French
392414

  • Fascial tissue dilator, single-use
CATALYSTEM BROACH SIZE 9
Smith & Nephew, Inc.
71314209
In Commercial Distribution

  • 00885556892190 ()

  • Size 9
71314209

  • Orthopaedic broach
CATALYSTEM COLLARLESS STEM HIGH OFFSET SIZE 9
Smith & Nephew, Inc.
71314089
In Commercial Distribution

  • 00885556892046 ()

  • Size 9
71314089

  • Coated hip femur prosthesis, modular
CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 9
Smith & Nephew, Inc.
71314069
In Commercial Distribution

  • 00885556891919 ()

  • Size 9
71314069

  • Coated hip femur prosthesis, modular
CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 9
Smith & Nephew, Inc.
71314049
In Commercial Distribution

  • 00885556891780 ()

  • Size 9
71314049

  • Coated hip femur prosthesis, modular
CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 9
Smith & Nephew, Inc.
71314029
In Commercial Distribution

  • 00885556891650 ()

  • Size 9
71314029

  • Coated hip femur prosthesis, modular
SPECIALTY SCORPIO SERIES 7000 TIBIAL TRAY TRIAL
Howmedica Osteonics Corp.
I-K2041KT09
In Commercial Distribution

  • 07613327325935 ()

  • Size: 9
I-K2041KT09

  • Knee tibia prosthesis trial, reusable
SPECIALTY SCORPIO PATELLA RESECTION GUARD
Howmedica Osteonics Corp.
I-K1774KP09
In Commercial Distribution

  • 07613327325492 ()

  • Size: 9
I-K1774KP09

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECIALTY SCORPIO MIS 4-IN-1 RESECTION BLOCK
Howmedica Osteonics Corp.
I-K1757KF09
In Commercial Distribution

  • 07613327325423 ()

  • Size: 9
I-K1757KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECIALTY SCORPIO PATELLA DRILL GUIDE
Howmedica Osteonics Corp.
I-K0580PT09
In Commercial Distribution

  • 07613327325089 ()

  • Size: 9
I-K0580PT09

  • Surgical drill guide, reusable
SPECIALTY SCORPIO ROTHMAN-STYLE TIBIAL BASEPLATE
Howmedica Osteonics Corp.
I-K0598BP09
In Commercial Distribution

  • 07613327316995 ()

  • Size: 9
I-K0598BP09

  • Surgical implant template, reusable
Specialty Accolade II Broach Trial
Howmedica Osteonics Corp.
I-H1862HB09
In Commercial Distribution

  • 07613327311808 ()

  • Size: 9
I-H1862HB09

  • Orthopaedic broach
SPECIALTY SCORPIO 4 IN 1 AR CUTTING BLOCK
Howmedica Osteonics Corp.
I-K0905KF09
In Commercial Distribution

  • 07613327310610 ()

  • Size: 9
I-K0905KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECIALTY ACCOLADE II DUAL INCISION BROACH-HANDLE
Howmedica Osteonics Corp.
I-H1855BH09
In Commercial Distribution

  • 07613327310429 ()

  • Size: 9
I-H1855BH09

  • Orthopaedic broach
SPECIALTY SCORPIO NRG PR FEMORAL 4:1 CUTTING BLOCK
Howmedica Osteonics Corp.
I-K3138KF09
In Commercial Distribution

  • 07613327308457 ()

  • Size: 9
I-K3138KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECIALTY SCORPIO SERIES 7000 FEMORAL CUTTING BLOCK
Howmedica Osteonics Corp.
I-K2885KF09
In Commercial Distribution

  • 07613327330649 ()

  • Size: 9
I-K2885KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable
SPECIALTY SCORPIO 3-IN-1 CUTTING BLOCK
Howmedica Osteonics Corp.
I-K3114KF09
In Commercial Distribution

  • 07613327329230 ()

  • Size: 9
I-K3114KF09

  • Orthopaedic prosthesis implantation positioning instrument, reusable
ArgoTrans Model 2/Macro 9" Line, Stopcock
ARGON MEDICAL DEVICES, INC.
041582505A
Not in Commercial Distribution

  • 20886333201703 ()
  • 00886333201709 ()

  • 9" Line
041582505A

  • Invasive blood pressure transducer set
PHYSICA POROUS CR - CoCrMo + PoroTi - Femoral Component #9 Cementless - Left
LIMACORPORATE SPA
6513.10.590
In Commercial Distribution

  • 08033390282062 ()

  • #9 Left
6513.10.590

  • Coated knee femur prosthesis
PHYSICA POROUS CR - CoCrMo + PoroTi - Femoral Component #9 Cementless - Right
LIMACORPORATE SPA
6513.10.190
In Commercial Distribution

  • 08033390281959 ()

  • #9 Right
6513.10.190

  • Coated knee femur prosthesis
Sterile-Eo
Dynarex Corporation
36271
In Commercial Distribution

  • 00840117315273 ()
  • 00840117315259 ()


  • Nasopharyngeal airway, single-use
Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Atos Medical AB
6131
In Commercial Distribution

  • 07331791015380 ()
6131

  • Tracheostoma protective filter
  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostomy tube neck holder, single-use
  • Airway device cleaning utensil, noninvasive, reusable
  • Tracheostoma shower shield
Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Atos Medical AB
6139
In Commercial Distribution

  • 07331791015465 ()
6139

  • Tracheostoma protective filter
  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostomy tube neck holder, single-use
  • Airway device cleaning utensil, noninvasive, reusable
  • Tracheostoma shower shield
Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush, Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Atos Medical AB
6135
In Commercial Distribution

  • 07331791015427 ()
6135

  • Tracheostoma protective filter
  • Tracheostomy tube, non-reinforced, non-customized, reusable
  • Tracheostomy tube neck holder, single-use
  • Airway device cleaning utensil, noninvasive, reusable
  • Tracheostoma shower shield
Multi pack of 18 tampons, 9 Regular and 9 Super absorbency
AL-BAD MASSUOT YITZHAK LTD
BRAUC18
In Commercial Distribution

  • 10011822583067 ()
  • 00011822583060 ()

  • Absorbency


  • Menstrual tampon, unscented
COSMETIC ICONIX UL LATERAL 022 T+9 A+9 R=0
AMERICAN ORTHODONTICS CORPORATION
393-7024G
Not in Commercial Distribution

  • 00190746116872 ()
393-7024G

  • Orthodontic bracket, metal
COSMETIC ICONIX UR LATERAL 022 T+9 A+9 R=0
AMERICAN ORTHODONTICS CORPORATION
393-7023G
Not in Commercial Distribution

  • 00190746116858 ()
393-7023G

  • Orthodontic bracket, metal
COSMETIC ICONIX UL LATERAL 018 T+9 A+9 R=0
AMERICAN ORTHODONTICS CORPORATION
393-7004G
Not in Commercial Distribution

  • 00190746116834 ()
393-7004G

  • Orthodontic bracket, metal
COSMETIC ICONIX UR LATERAL 018 T+9 A+9 R=0
AMERICAN ORTHODONTICS CORPORATION
393-7003G
Not in Commercial Distribution

  • 00190746116810 ()
393-7003G

  • Orthodontic bracket, metal
Frazier Suction Tube 9", 170mm WL, 9 french, 90deg with stylette
GSOURCE LLC
gS 75.9317
In Commercial Distribution

  • 00840314238726 ()
gS 75.9317

  • ENT suction dissector
9 mm x 25 mm x 9 mm 6 Degree Lordotic
Ortho Development Corporation
551-7409
Not in Commercial Distribution

  • 00822409027460 ()

  • Angle: 6 degree
  • Length: 25 Millimeter
  • Width: 9 Millimeter
  • Height: 9 Millimeter


  • Polymeric spinal interbody fusion cage
9 mm x 25 mm x 9 mm 3 Degree Lordotic
Ortho Development Corporation
551-7309
Not in Commercial Distribution

  • 00822409027422 ()

  • Angle: 3 degree
  • Width: 9 Millimeter
  • Height: 9 Millimeter
  • Length: 25 Millimeter


  • Polymeric spinal interbody fusion cage
9 mm x 20 mm x 9 mm 6 Degree Lordotic
Ortho Development Corporation
551-7209
Not in Commercial Distribution

  • 00822409027323 ()

  • Height: 9 Millimeter
  • Length: 20 Millimeter
  • Angle: 6 degree
  • Width: 9 Millimeter


  • Polymeric spinal interbody fusion cage
9 mm x 20 mm x 9 mm 3 Degree Lordotic
Ortho Development Corporation
551-7109
Not in Commercial Distribution

  • 00822409027286 ()

  • Angle: 3 degree
  • Width: 9 Millimeter
  • Height: 9 Millimeter
  • Length: 20 Millimeter


  • Polymeric spinal interbody fusion cage
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