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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 - 00889024511903

No Description
Zimmer, Inc.
SSI004484
In Commercial Distribution

  • 00889024511903 ()

  • Height: 14 Millimeter
  • 8-9/CD L - 14
SSI004484

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511897

No Description
Zimmer, Inc.
SSI004483
In Commercial Distribution

  • 00889024511897 ()

  • 8-9/CD L - 13
  • Height: 13 Millimeter
SSI004483

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511880

No Description
Zimmer, Inc.
SSI004482
In Commercial Distribution

  • 00889024511880 ()

  • Height: 12 Millimeter
  • 8-9/CD L - 12
SSI004482

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511873

No Description
Zimmer, Inc.
SSI004481
In Commercial Distribution

  • 00889024511873 ()

  • 8-9/CD L - 11
  • Height: 11 Millimeter
SSI004481

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511866

No Description
Zimmer, Inc.
SSI004480
In Commercial Distribution

  • 00889024511866 ()

  • Height: 10 Millimeter
  • 8-9/CD L - 10
SSI004480

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511750

No Description
Zimmer, Inc.
SSI004469
In Commercial Distribution

  • 00889024511750 ()

  • 6-7/CD R - 14
  • Height: 14 Millimeter
SSI004469

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511743

No Description
Zimmer, Inc.
SSI004468
In Commercial Distribution

  • 00889024511743 ()

  • Height: 13 Millimeter
  • 6-7/CD R - 13
SSI004468

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511736

No Description
Zimmer, Inc.
SSI004467
In Commercial Distribution

  • 00889024511736 ()

  • 6-7/CD R - 12
  • Height: 12 Millimeter
SSI004467

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511729

No Description
Zimmer, Inc.
SSI004466
In Commercial Distribution

  • 00889024511729 ()

  • Height: 11 Millimeter
  • 6-7/CD R - 11
SSI004466

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511712

No Description
Zimmer, Inc.
SSI004465
In Commercial Distribution

  • 00889024511712 ()

  • 6-7/CD R - 10
  • Height: 10 Millimeter
SSI004465

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511705

No Description
Zimmer, Inc.
SSI004464
In Commercial Distribution

  • 00889024511705 ()

  • Height: 14 Millimeter
  • 6-7/CD L - 14
SSI004464

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511699

No Description
Zimmer, Inc.
SSI004463
In Commercial Distribution

  • 00889024511699 ()

  • 6-7/CD L - 13
  • Height: 13 Millimeter
SSI004463

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511675

No Description
Zimmer, Inc.
SSI004461
In Commercial Distribution

  • 00889024511675 ()

  • 6-7/CD L - 11
  • Height: 11 Millimeter
SSI004461

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511552

No Description
Zimmer, Inc.
SSI004449
In Commercial Distribution

  • 00889024511552 ()

  • Height: 14 Millimeter
  • 4-5/CD R - 14
SSI004449

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511545

No Description
Zimmer, Inc.
SSI004448
In Commercial Distribution

  • 00889024511545 ()

  • 4-5/CD R - 13
  • Height: 13 Millimeter
SSI004448

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511484

No Description
Zimmer, Inc.
SSI004442
In Commercial Distribution

  • 00889024511484 ()

  • 4-5/CD L - 12
  • Height: 12 Millimeter
SSI004442

  • Knee tibia prosthesis trial, reusable

Persona - 00889024511460

No Description
Zimmer, Inc.
SSI004440
In Commercial Distribution

  • 00889024511460 ()

  • 4-5/CD L - 10
  • Height: 10 Millimeter
SSI004440

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245785

No Description
Zimmer, Inc.
42-5279-003-04
In Commercial Distribution

  • 00889024245785 ()

  • 14mm Thickness, Size CD
42-5279-003-04

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245778

No Description
Zimmer, Inc.
42-5279-003-03
In Commercial Distribution

  • 00889024245778 ()

  • 13mm Thickness, Size CD
42-5279-003-03

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024238473

No Description
Zimmer, Inc.
42-5170-003-13
In Commercial Distribution

  • 00889024238473 ()

  • +6mm Thickness, Size CD
42-5170-003-13

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024238459

No Description
Zimmer, Inc.
42-5170-003-03
In Commercial Distribution

  • 00889024238459 ()

  • +0mm Thickness, Size CD
42-5170-003-03

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024238930

No Description
Zimmer, Inc.
42-5176-003-13
In Commercial Distribution

  • 00889024238930 ()

  • +6 Thickness, Size CD
42-5176-003-13

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024238916

No Description
Zimmer, Inc.
42-5176-003-03
In Commercial Distribution

  • 00889024238916 ()

  • +0 Thickness, Size CD
42-5176-003-03

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245754

No Description
Zimmer, Inc.
42-5279-003-01
In Commercial Distribution

  • 00889024245754 ()

  • 11mm Thickness, Size CD
42-5279-003-01

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245747

No Description
Zimmer, Inc.
42-5279-003-00
In Commercial Distribution

  • 00889024245747 ()

  • 10mm Thickness, Size CD
42-5279-003-00

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245440

No Description
Zimmer, Inc.
42-5276-003-13
In Commercial Distribution

  • 00889024245440 ()

  • +6 Thickness, Size CD
42-5276-003-13

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024245426

No Description
Zimmer, Inc.
42-5276-003-03
In Commercial Distribution

  • 00889024245426 ()

  • +0 Thickness, Size CD
42-5276-003-03

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024244986

No Description
Zimmer, Inc.
42-5270-003-13
In Commercial Distribution

  • 00889024244986 ()

  • +6mm Thickness, Size CD
42-5270-003-13

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024244962

No Description
Zimmer, Inc.
42-5270-003-03
In Commercial Distribution

  • 00889024244962 ()

  • +0mm Thickness, Size CD
42-5270-003-03

  • 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 - 03610521185987

BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610521185987 ()

  • 1 Each
12006557

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

Phoenix Diagnostics - 00852676007049

Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems
PHOENIX DIAGNOSTICS, INC.
3-221
In Commercial Distribution

  • 01085267600704 ()
  • 00852676007049 ()

  • Total Volume: 460 Milliliter


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

BioPlex 2200 - 00847865012508

APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012508 ()

  • 1 Each
6651975A

  • Phospholipid antibody IVD, kit, multiplex

M SERIES - 00847946002992

Defibrillator ,MAIN,BASIC-3,3/5LEAD,DC,EL,RC,SM,CD, ENG
Zoll Medical Corporation
40010021000003010
In Commercial Distribution

  • 00847946002992 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

M SERIES - 00847946005252

Defibrillator ,MAIN, BASIC-3 SPO2/12LEAD AC/EL/RC/SM/CD
Zoll Medical Corporation
40021211000003010
In Commercial Distribution

  • 00847946005252 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

NA - 07630031733672

CD Ø 1.65 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733672 ()

  • Outer Diameter: 1.65 Millimeter
046.757

  • Dental implant internal thread shaping tool

NA - 07630031733665

CD Ø 1.45 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733665 ()

  • Outer Diameter: 1.45 Millimeter
046.756

  • Dental implant internal thread shaping tool

NA - 07630031733122

CD Ø 1.3 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733122 ()

  • Outer Diameter: 1.3 Millimeter
026.0127

  • Dental implant internal thread shaping tool

Sherlock - 00801741124396

SHERLOCK 3CG FOR SR6 USB UPGRADE KIT W/ IFU CD
Bard Access Systems, Inc.
9770137
In Commercial Distribution

  • 00801741124396 ()
9770137

  • Central venous catheter navigation system, electrocardiographic/magnetic

BioPlex® 2200 - 03610520519813

BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD
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