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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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Persona Knee System - 00889024472372

No Description
Zimmer, Inc.
82-0156-859-00
In Commercial Distribution

  • 00889024472372 ()

  • Femur: 1-2, Tibia: C-D
  • Height: 10 Millimeter
82-0156-859-00

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472068

No Description
Zimmer, Inc.
82-0156-858-29
In Commercial Distribution

  • 00889024472068 ()

  • Height: 14 Millimeter
  • Femur: 3-9, Tibia: C-D
82-0156-858-29

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472051

No Description
Zimmer, Inc.
82-0156-858-28
In Commercial Distribution

  • 00889024472051 ()

  • Femur: 3-9, Tibia: C-D
  • Height: 13 Millimeter
82-0156-858-28

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472044

No Description
Zimmer, Inc.
82-0156-858-27
In Commercial Distribution

  • 00889024472044 ()

  • Height: 12 Millimeter
  • Femur: 3-9, Tibia: C-D
82-0156-858-27

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472037

No Description
Zimmer, Inc.
82-0156-858-26
In Commercial Distribution

  • 00889024472037 ()

  • Femur: 3-9, Tibia: C-D
  • Height: 11 Millimeter
82-0156-858-26

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472020

No Description
Zimmer, Inc.
82-0156-858-25
In Commercial Distribution

  • 00889024472020 ()

  • Height: 10 Millimeter
  • Femur: 3-9, Tibia: C-D
82-0156-858-25

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472013

No Description
Zimmer, Inc.
82-0156-858-24
In Commercial Distribution

  • 00889024472013 ()

  • Femur: 3-9, Tibia: C-D
  • Height: 14 Millimeter
82-0156-858-24

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024472006

No Description
Zimmer, Inc.
82-0156-858-23
In Commercial Distribution

  • 00889024472006 ()

  • Height: 13 Millimeter
  • Femur: 3-9, Tibia: C-D
82-0156-858-23

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024471993

No Description
Zimmer, Inc.
82-0156-858-22
In Commercial Distribution

  • 00889024471993 ()

  • Femur: 3-9, Tibia: C-D
  • Height: 12 Millimeter
82-0156-858-22

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024471986

No Description
Zimmer, Inc.
82-0156-858-21
In Commercial Distribution

  • 00889024471986 ()

  • Height: 11 Millimeter
  • Femur: 3-9, Tibia: C-D
82-0156-858-21

  • Knee tibia prosthesis trial, reusable

Persona Knee System - 00889024471979

No Description
Zimmer, Inc.
82-0156-858-20
In Commercial Distribution

  • 00889024471979 ()

  • Femur: 3-9, Tibia: C-D
  • Height: 10 Millimeter
82-0156-858-20

  • Knee tibia prosthesis trial, reusable

HyperSound - 00869138000203

Directed audio solution employing a fundamentally new way to deliver sound. Device is intended to improve sound clarity and speech intelligibility for individuals with hearing loss. The device is programmable and customizable by a hearing professional to a listener's hearing profile and preferences and other operating parameters are adjustable by the user. The device consists of an amplifier and specialized speakers connectable to an audio source (e.g., television, CD player); the speakers emit an ultrasonic beam with sound waves reproduced within the beam directed at the user. It is intended to be used with or without a hearing aid(s). An internal tinnitus software module may be activated and fitted by a hearing care professional for patient home use in the temporary relief of tinnitus symptoms. Upon module activation the device generates and delivers personalized sound output to tinnitus patients with or without hearing loss and with or without hearing aids.
TURTLE BEACH CORPORATION
HyperSound Clear 500P
Not in Commercial Distribution

  • 00869138000203 ()
HPS-0500-04

  • Directed listening device

BioPlex 2200 - 03610520563939

BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520506462

BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay

BioPlex 2200 - 03610520506349

25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US
BIO-RAD LABORATORIES, INC.
SW4.2 V3
In Commercial Distribution

  • 03610520506349 ()

  • 1 Each
6653775A

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

BioPlex 2200 - 03610520150269

BioPlex 2200 ToRC IgM Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520150269 ()

  • 1 Each
12000671

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

Soprano® 10 Livento® press - 07640173094791

Soprano® 10 Livento® press Shade C-D Kit
Cendres+Métaux SA
08055074
In Commercial Distribution

  • 07640173094791 ()
08055074

  • Dental appliance fabrication material, ceramic

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor - 00817980021396

EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software

Task Force® Monitor Software - 09120073931931

Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor

BioPlex 2200 - 00847865012331

ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865012331 ()

  • 1 Each
6651170D

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

BioPlex 2200 - 00847865002448

ANA Screen with MDSS Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
Not in Commercial Distribution

  • 00847865002448 ()

  • 1 Each
6651170C

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

Persona® - 00889024245730

No Description
Zimmer, Inc.
42-5279-002-04
In Commercial Distribution

  • 00889024245730 ()

  • Size CD 14 mm Thickness
42-5279-002-04

  • Knee tibia prosthesis trial, reusable

PERSONA™ - 00889024245723

No Description
Zimmer, Inc.
42-5279-002-03
In Commercial Distribution

  • 00889024245723 ()

  • Size CD, 13 mm Thickness
42-5279-002-03

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024245716

No Description
Zimmer, Inc.
42-5279-002-02
In Commercial Distribution

  • 00889024245716 ()

  • Size CD 12 mm Thickness
42-5279-002-02

  • Knee tibia prosthesis trial, reusable

PERSONA™ - 00889024245709

No Description
Zimmer, Inc.
42-5279-002-01
In Commercial Distribution

  • 00889024245709 ()

  • Size CD, 11 mm Thickness
42-5279-002-01

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024245693

No Description
Zimmer, Inc.
42-5279-002-00
In Commercial Distribution

  • 00889024245693 ()

  • Size CD 10 mm Thickness
42-5279-002-00

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488625

No Description
Zimmer, Inc.
82-0156-858-63
In Commercial Distribution

  • 00889024488625 ()

  • CR Provisional, 3-9/ C-D, Right
  • Height: 9 Millimeter
82-0156-858-63

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488618

No Description
Zimmer, Inc.
82-0156-858-62
In Commercial Distribution

  • 00889024488618 ()

  • Height: 8 Millimeter
  • CR Provisional, 3-9/ C-D, Right
82-0156-858-62

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488601

No Description
Zimmer, Inc.
82-0156-858-61
In Commercial Distribution

  • 00889024488601 ()

  • CR Provisional, 3-9/ C-D, Left
  • Height: 9 Millimeter
82-0156-858-61

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488595

No Description
Zimmer, Inc.
82-0156-858-60
In Commercial Distribution

  • 00889024488595 ()

  • Height: 8 Millimeter
  • CR Provisional, 3-9/ C-D, Left
82-0156-858-60

  • Knee tibia prosthesis trial, reusable
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