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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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Opti-Handles - 00841962119900

Opti-Handles, 60cm (24") set of 2
Qfix
RT-4457
In Commercial Distribution

  • 00841962119900 ()
RT-4457

  • Indexed-immobilization patient positioning system

Solar™ Interbody Fusion System - 00842048182009

30 X 24 Central Spreader Paddle
DEGEN MEDICAL, INC.
12-11S3024
In Commercial Distribution

  • 00842048182009 ()
12-11S3024

  • Bone lever/elevator, reusable

Y-Port Feeding Adapter - 00842071114718

24 FR Y-Port Replacement (ISOSAF, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-2024-ISOSAF
Not in Commercial Distribution

  • 00842071114886 ()
  • 00842071114718 ()

  • Catheter Gauge: 24 French
E4-2024-ISOSAF, 4-2024-ISOSAF

  • ENFit/non-ISO80369-standardized linear connector

Y-Port Feeding Adapter - 00842071114701

24 FR Y-Port Replacement (Hybrid, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-2024-H
Not in Commercial Distribution

  • 00842071114879 ()
  • 00842071114701 ()

  • Catheter Gauge: 24 French
E4-2024-H, 4-2024-H

  • ENFit/non-ISO80369-standardized linear connector

MD-Vue™ Lateral Discectomy System - 00840019967310

Trial 24 x 18 mm 15°
PRECISION SPINE, INC.
60-TS-5418
In Commercial Distribution

  • 00840019967310 ()
60-TS-5418

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD-Vue™ Lateral Discectomy System - 00840019967303

Angled Trial 24 X 16mm 0°
PRECISION SPINE, INC.
60-TA-0416
In Commercial Distribution

  • 00840019967303 ()
60-TA-0416

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD-Vue™ Lateral Discectomy System - 00840019967297

Trial 24 x 16 mm 15°
PRECISION SPINE, INC.
60-TS-5416
In Commercial Distribution

  • 00840019967297 ()
60-TS-5416

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD-Vue™ Lateral Discectomy System - 00840019967280

Trial 24 x 16 mm 0°
PRECISION SPINE, INC.
60-TS-0416
In Commercial Distribution

  • 00840019967280 ()
60-TS-0416

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD-Vue™ Lateral Discectomy System - 00840019967273

Trial 24 x 16 mm 7°
PRECISION SPINE, INC.
60-TS-7416
In Commercial Distribution

  • 00840019967273 ()
60-TS-7416

  • Orthopaedic surgical procedure kit, non-medicated, reusable

MD-Vue™ Lateral Discectomy System - 00840019967266

Angled Trial 24 X 14mm 0°
PRECISION SPINE, INC.
60-TA-0414
In Commercial Distribution

  • 00840019967266 ()
60-TA-0414

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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