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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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ArgoTrans Model 2/Macro - 00886333201709

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

CATALYSTEM - 00885556892046

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

  • 00885556892046 ()

  • Size 9
71314089

  • Coated hip femur prosthesis, modular

CATALYSTEM - 00885556891919

CATALYSTEM COLLARLESS STEM STANDARD OFFSET SIZE 9
Smith & Nephew, Inc.
71314069
In Commercial Distribution

  • 00885556891919 ()

  • Size 9
71314069

  • Coated hip femur prosthesis, modular

CATALYSTEM - 00885556891780

CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 9
Smith & Nephew, Inc.
71314049
In Commercial Distribution

  • 00885556891780 ()

  • Size 9
71314049

  • Coated hip femur prosthesis, modular

CATALYSTEM - 00885556891650

CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 9
Smith & Nephew, Inc.
71314029
In Commercial Distribution

  • 00885556891650 ()

  • Size 9
71314029

  • Coated hip femur prosthesis, modular

OSS™ - 00887868467707

No Description
Biomet Orthopedics, LLC
110018679
In Commercial Distribution

  • 00887868467707 ()

  • 9 cm
110018679

  • Knee tibia prosthesis trial, reusable

OSS™ - 00887868467691

No Description
Biomet Orthopedics, LLC
110018678
In Commercial Distribution

  • 00887868467691 ()

  • 9 cm
110018678

  • Knee tibia prosthesis trial, reusable

OSS™ - 00887868467684

No Description
Biomet Orthopedics, LLC
110018677
In Commercial Distribution

  • 00887868467684 ()

  • 9 cm
110018677

  • Knee tibia prosthesis trial, reusable

OSS™ - 00887868467523

No Description
Biomet Orthopedics, LLC
110018654
In Commercial Distribution

  • 00887868467523 ()

  • 9 cm
110018654

  • Knee femur prosthesis trial, reusable

PHYSICA POROUS CR - CoCrMo + PoroTi - 08033390282062

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 - 08033390281959

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

Resp-O2 Nasopharyngeal Airway Kit, 9 NPA + 9 Packs of DynaLube - 00840117315273

Sterile-Eo
Dynarex Corporation
36271
In Commercial Distribution

  • 00840117315273 ()
  • 00840117315259 ()


  • Nasopharyngeal airway, single-use

Provox Life LP Kit 10 - LT 9/36, 9/55 - 07331791015465

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 Life LP Kit 6 - LT 9/36, 9/55 - 07331791015427

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

Provox Life LP Kit 2 - LT 9/36, 9/55 - 07331791015380

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

Persona® Trabecular Metal® - 00889024561250

No Description
Zimmer, Inc.
42-5574-066-15
In Commercial Distribution

  • 00889024561250 ()

  • Size 9, 9+, 15 mm, Thickness
42-5574-066-15

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561205

No Description
Zimmer, Inc.
42-5574-066-10
In Commercial Distribution

  • 00889024561205 ()

  • Size 9, 9+, 10 mm, Thickness
42-5574-066-10

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561137

No Description
Zimmer, Inc.
42-5574-066-05
In Commercial Distribution

  • 00889024561137 ()

  • Size 9, 9+, 5 mm, Thickness
42-5574-066-05

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561069

No Description
Zimmer, Inc.
42-5572-066-15
In Commercial Distribution

  • 00889024561069 ()

  • Size 9, 9+, 15 mm, Thickness
42-5572-066-15

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561014

No Description
Zimmer, Inc.
42-5572-066-10
In Commercial Distribution

  • 00889024561014 ()

  • Size 9, 9+, 10 mm, Thickness
42-5572-066-10

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024560949

No Description
Zimmer, Inc.
42-5572-066-05
In Commercial Distribution

  • 00889024560949 ()

  • Size 9, 9+, 5 mm, Thickness
42-5572-066-05

  • Knee arthroplasty wedge

Persona® - 00889024557055

No Description
Zimmer, Inc.
42-5568-066-15
In Commercial Distribution

  • 00889024557055 ()

  • Size 9, 9+, 15 mm, Thickness
42-5568-066-15

  • Knee arthroplasty wedge

Persona® - 00889024557000

No Description
Zimmer, Inc.
42-5568-066-10
In Commercial Distribution

  • 00889024557000 ()

  • Size 9, 9+, 10 mm, Thickness
42-5568-066-10

  • Knee arthroplasty wedge

Persona® - 00889024556935

No Description
Zimmer, Inc.
42-5568-066-05
In Commercial Distribution

  • 00889024556935 ()

  • Size 9, 9+, 5 mm, Thickness
42-5568-066-05

  • Knee arthroplasty wedge

Persona® - 00889024556867

No Description
Zimmer, Inc.
42-5566-066-15
In Commercial Distribution

  • 00889024556867 ()

  • Size 9, 9+, 15 mm, Thickness
42-5566-066-15

  • Knee arthroplasty wedge

Persona® - 00889024556812

No Description
Zimmer, Inc.
42-5566-066-10
In Commercial Distribution

  • 00889024556812 ()

  • Size 9, 9+, 10 mm, Thickness
42-5566-066-10

  • Knee arthroplasty wedge

Persona® - 00889024556744

No Description
Zimmer, Inc.
42-5566-066-05
In Commercial Distribution

  • 00889024556744 ()

  • Size 9, 9+, 5 mm, Thickness
42-5566-066-05

  • Knee arthroplasty wedge

THREADED STEINMANN PINS, DOUBLE END TROCAR POINT - 00887868016561

No Description
Biomet Orthopedics, LLC
1617-64-000
In Commercial Distribution

  • 00887868016561 ()
  • 70887868016560 ()

  • 9/64" (3.6MM) X 9" (228.6MM)
161764000

  • Orthopaedic bone wire

Integra® Jarit® - 10381780032113

Integra® Jarit® Steinmann Pin, 9/64*9" Double Trocar, Partially Threaded
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X381623
In Commercial Distribution

  • M274X3816230 ()
  • 10381780032113 ()

  • 9/64 in X 9 in
X381623

  • Orthopaedic bone pin, non-bioabsorbable

Integra® Jarit® - 10381780032076

Integra® Jarit® Steinmann Pin, 9/64*9" Smooth, Double Trocar
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X381619
In Commercial Distribution

  • M274X3816190 ()
  • 10381780032076 ()

  • 9/64 in X 9 in
X381619

  • Orthopaedic bone pin, non-bioabsorbable

Miltex® - 10381780031802

Miltex® Steinmann Pin ,9/64*9"Smooth, Double Trocar ,Partially Threaded
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
270512
In Commercial Distribution

  • H8342705120 ()
  • 10381780031802 ()

  • 9/64 in X 9 in
270512

  • Orthopaedic bone pin, non-bioabsorbable

S-Core™ - 00850017962125

9 mm x 7.5 mm Cannulated Drill and 9 mm Countersink, Non-Sterile
SUBCHONDRAL SOLUTIONS, INC.
10-2009-P
In Commercial Distribution

  • 10850017962122 ()
  • 00850017962125 ()

  • Height: 9 Millimeter
  • Length: 7.5 Millimeter
  • Outer Diameter: 9 Millimeter
10-2009-P

  • Orthopaedic bone screw, non-bioabsorbable, sterile

SPETZLER MACROVAC® - 00650551001874

9 FRENCH, STRAIGHT TIP WITH 45 DEGREE BEND, 9" LENGTH, SATIN FINISH
PMT CORPORATION
3201-09S-09-094-SF
In Commercial Distribution

  • 00650551001874 ()


  • Surgical irrigation/aspiration handpiece, reusable

C-QUR - 00650862315059

C-QUR MESH, 3.54 in. x 3.54 in. (9 cm x 9 cm)
Atrium Medical Corporation
31505
Not in Commercial Distribution

  • 00650862315059 ()


  • Extra-gynaecological surgical mesh, composite-polymer

Surgical Direct - B382SD9114311050

9 1/4 inch Frazier Suction Tube, Round Hole, Straight 9 FR
Surgical Direct, Inc.
SD911431105
In Commercial Distribution

  • B382SD9114311050 ()
SD911431105

  • Suction system catheter, general-purpose

Surgical Direct - B382SD9227151110

9 inch Micro Kerrison, 2mm, 40° Up TW 2mm, WL 9 inch
Surgical Direct, Inc.
SD922715111
In Commercial Distribution

  • B382SD9227151110 ()
SD922715111

  • Orthopaedic joint/limb rongeur

ORIO - M824L7409098261

ORIO-PL PLIF CAGE 9mm WIDE, 8¿ LORDOSIS, 9 X 9 X 26mm
SPINECRAFT, LLC
L7409-09-826
In Commercial Distribution

  • M824L7409098261 ()


  • Polymeric spinal interbody fusion cage

ORIO - M824L7409098241

ORIO-PL PLIF CAGE 9mm WIDE, 8¿ LORDOSIS, 9 X 9 X 24mm
SPINECRAFT, LLC
L7409-09-824
In Commercial Distribution

  • M824L7409098241 ()


  • Polymeric spinal interbody fusion cage

ORIO - M824L7409098221

ORIO-PL PLIF CAGE 9mm WIDE, 8¿ LORDOSIS, 9 X 9 X 22mm
SPINECRAFT, LLC
L7409-09-822
In Commercial Distribution

  • M824L7409098221 ()


  • Polymeric spinal interbody fusion cage

ORIO - M824L7109095261

ORIO-PL PLIF CAGE 9mm WIDE, 5¿ LORDOSIS, 9 X 9 X 26mm
SPINECRAFT, LLC
L7109-09-526
In Commercial Distribution

  • M824L7109095261 ()


  • Polymeric spinal interbody fusion cage
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