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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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Solar™ Interbody Fusion System - 00842048150374

32 X 24 Central Spreader Paddle
DEGEN MEDICAL, INC.
12-11S3224
In Commercial Distribution

  • 00842048150374 ()
12-11S3224

  • Bone lever/elevator, reusable

Axis Plate - 00842078117828

Locking Screw - 4.5 mm x 24
EXTREMITY MEDICAL, LLC
148-45124
In Commercial Distribution

  • 00842078117828 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Axis Plate - 00842078117590

Non-Locking Screw - 4.5 mm x 24
EXTREMITY MEDICAL, LLC
148-45024
In Commercial Distribution

  • 00842078117590 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Axis Plate - 00842078117484

Locking Screw - 3.5 mm x 24
EXTREMITY MEDICAL, LLC
148-35124
In Commercial Distribution

  • 00842078117484 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Axis Plate - 00842078117378

Non-Locking Screw - 3.5 mm x 24
EXTREMITY MEDICAL, LLC
148-35024
In Commercial Distribution

  • 00842078117378 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

AlignX - 00842078116333

Non-Locking Screw - 5.0 x 24 mm
EXTREMITY MEDICAL, LLC
136-50024
In Commercial Distribution

  • 00842078116333 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

AlignX - 00842078110621

Locking Screw - 4.0 x 24 mm
EXTREMITY MEDICAL, LLC
136-40124
In Commercial Distribution

  • 00842078110621 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

AlignX - 00842078110492

Non-Locking Screw - 4.0 x 24 mm
EXTREMITY MEDICAL, LLC
136-40024
In Commercial Distribution

  • 00842078110492 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Y-Port Feeding Adapter - 00842071133443

24 FR Y-Port Replacement (Pouched), MDR
APPLIED MEDICAL TECHNOLOGY, INC.
E4-2024
In Commercial Distribution

  • 00842071133542 ()
  • 00842071133443 ()

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

  • Luer/non-ISO80369-standardized linear connector, single-use

Y-Port Feeding Adapter - 00842071131753

24 FR Y-Port Replacement (ISOSAF, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-2024-ISOSAF
In Commercial Distribution

  • 00842071131654 ()
  • 00842071131753 ()

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

  • ENFit/non-ISO80369-standardized linear connector
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