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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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ACU-DTM - 10814105021214

ACU-DTM, Dermatophyte Test Medium, 24/bX
ACUDERM, INC.
M101
In Commercial Distribution

  • 00814105021217 ()
  • 10814105021214 ()


  • Multiple dermatophyte species culture isolate identification IVD, kit

ACU-DTM - 10814105021207

ACU-DTM, Dermatophyte Test Medium, 24/bX
ACUDERM, INC.
M101
In Commercial Distribution

  • 00814105021200 ()
  • 10814105021207 ()


  • Multiple dermatophyte species culture isolate identification IVD, kit

Proficient® Posterior Cervical Spine System - 10840642125283

Smooth-Shank Screw, 4.2 mm × 24 mm
Spine Wave, Inc.
11-9424
In Commercial Distribution

  • 10840642125283 ()
11-9424

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642125191

Smooth-Shank Screw, 3.8 mm × 24 mm
Spine Wave, Inc.
11-9324
In Commercial Distribution

  • 10840642125191 ()
11-9324

  • Spinal bone screw, non-bioabsorbable

AADCO - 00840348525564

STERILE DOME BAG 24" 20/CS
AADCO MEDICAL, INC.
DB-0024
In Commercial Distribution

  • 00840348525571 ()
  • 00840348525564 ()
DB-0024

  • Sterilization packaging, single-use

Proficient® Posterior Cervical Spine System - 10840642122800

Translational Screw, 4.2 mm × 24 mm
Spine Wave, Inc.
11-9724
In Commercial Distribution

  • 10840642122800 ()
11-9724

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642122572

Translational Screw, 3.8 mm × 24 mm
Spine Wave, Inc.
11-9903
In Commercial Distribution

  • 10840642122572 ()
11-9903

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642119152

Screw, 3.8 mm X 24 mm
Spine Wave, Inc.
21-8325
In Commercial Distribution

  • 10840642119152 ()
21-8325

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642115093

Screw, 5.0 mm x 24 mm
Spine Wave, Inc.
11-8442
In Commercial Distribution

  • 10840642115093 ()
11-8442

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642123821

Translational Screw, 5.5 mm × 24 mm
Spine Wave, Inc.
11-9857
In Commercial Distribution

  • 10840642123821 ()
11-9857

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642123654

Translational Screw, 5.0 mm × 24 mm
Spine Wave, Inc.
11-9823
In Commercial Distribution

  • 10840642123654 ()
11-9823

  • Spinal bone screw, non-bioabsorbable

Proficient® Posterior Cervical Spine System - 10840642123487

Translational Screw, 4.6 mm × 24 mm
Spine Wave, Inc.
11-9789
In Commercial Distribution

  • 10840642123487 ()
11-9789

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642119381

Screw, 4.2 mm X 24 mm
Spine Wave, Inc.
21-8371
In Commercial Distribution

  • 10840642119381 ()
21-8371

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642109740

Screw, 5.5 mm x 24 mm
Spine Wave, Inc.
11-8078
In Commercial Distribution

  • 10840642109740 ()
11-8078

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642109689

Screw, 4.6 mm x 24 mm
Spine Wave, Inc.
11-8055
In Commercial Distribution

  • 10840642109689 ()
11-8055

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642109610

Screw, 4.2 mm x 24 mm
Spine Wave, Inc.
11-8032
In Commercial Distribution

  • 10840642109610 ()
11-8032

  • Spinal bone screw, non-bioabsorbable

Proficient™ Posterior Cervical Spine System - 10840642109481

Screw, 3.8 mm x 24 mm
Spine Wave, Inc.
11-8009
In Commercial Distribution

  • 10840642109481 ()
11-8009

  • Spinal bone screw, non-bioabsorbable

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
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