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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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LEONE SPA - 08033707023012

CALIBRA BANDS 2ND MOLAR n.SUL 9
LEONE SPA
E2305-09
In Commercial Distribution

  • 08033707023012 ()
E2305-09

  • Orthodontic metal band

LEONE SPA - 08033707022688

CALIBRA BANDS 2ND MOLAR n.SUL 9
LEONE SPA
E2300-09
In Commercial Distribution

  • 08033707022688 ()
E2300-09

  • Orthodontic metal band

LEONE SPA - 08033707022367

CALIBRA BANDS 2ND MOLAR n.SUR 9
LEONE SPA
E2205-09
In Commercial Distribution

  • 08033707022367 ()
E2205-09

  • Orthodontic metal band

LEONE SPA - 08033707018711

CALIBRA 1ST MOLAR BANDS n.LL 9
LEONE SPA
E1705-09
In Commercial Distribution

  • 08033707018711 ()
E1705-09

  • Orthodontic metal band

Vault C ACDF System - 00840019916851

Rasp, 7° Lordosis, 18x15 - 9/10mm
PRECISION SPINE, INC.
37-RS-7810
In Commercial Distribution

  • 00840019916851 ()
37-RS-7810

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916776

Rasp, 7° Lordosis, 14x12 - 9/10mm
PRECISION SPINE, INC.
37-RS-7410
In Commercial Distribution

  • 00840019916776 ()
37-RS-7410

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916691

Rasp, 0° Lordosis, 16x14 - 9/10mm
PRECISION SPINE, INC.
37-RS-0610
In Commercial Distribution

  • 00840019916691 ()
37-RS-0610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916653

Rasp, 0° Lordosis, 14x12 - 9/10mm
PRECISION SPINE, INC.
37-RS-0410
In Commercial Distribution

  • 00840019916653 ()
37-RS-0410

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916615

Trial, 7° Lordosis, 18x15 - 9/10mm
PRECISION SPINE, INC.
37-TN-7810
In Commercial Distribution

  • 00840019916615 ()
37-TN-7810

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916578

Trial, 7° Lordosis, 16x14 - 9/10mm
PRECISION SPINE, INC.
37-TN-7610
In Commercial Distribution

  • 00840019916578 ()
37-TN-7610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916530

Trial, 7° Lordosis, 14x12 - 9/10mm
PRECISION SPINE, INC.
37-TN-7410
In Commercial Distribution

  • 00840019916530 ()
37-TN-7410

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916493

Trial, 0° Lordosis, 18x15 - 9/10mm
PRECISION SPINE, INC.
37-TN-0810
In Commercial Distribution

  • 00840019916493 ()
37-TN-0810

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916455

Trial, 0° Lordosis, 16x14 - 9/10mm
PRECISION SPINE, INC.
37-TN-0610
In Commercial Distribution

  • 00840019916455 ()
37-TN-0610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916417

Trial, 0° Lordosis, 14x12 - 9/10mm
PRECISION SPINE, INC.
37-TN-0410
In Commercial Distribution

  • 00840019916417 ()
37-TN-0410

  • Orthopaedic surgical procedure kit, non-medicated, reusable

ACUFEX - 03596010091635

9 MM ENDOSCOPIC CANNULATED DRILL BIT
Smith & Nephew, Inc.
013662
In Commercial Distribution

  • 03596010091635 ()
013662

  • General internal orthopaedic fixation system implantation kit

Vault C ACDF System - 00840019916813

Rasp, 7° Lordosis, 16x14 - 9/10mm
PRECISION SPINE, INC.
37-RS-7610
In Commercial Distribution

  • 00840019916813 ()
37-RS-7610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Vault C ACDF System - 00840019916738

Rasp, 0° Lordosis, 18x15 - 9/10mm
PRECISION SPINE, INC.
37-RS-0810
In Commercial Distribution

  • 00840019916738 ()
37-RS-0810

  • Orthopaedic surgical procedure kit, non-medicated, reusable

LEONE SPA - 08033707017967

CALIBRA 1ST MOLAR BANDS n.LL 9
LEONE SPA
E1700-09
In Commercial Distribution

  • 08033707017967 ()
E1700-09

  • Orthodontic metal band

LEONE SPA - 08033707017608

CALIBRA 1ST MOLAR BANDS n.LR 9
LEONE SPA
E1605-09
In Commercial Distribution

  • 08033707017608 ()
E1605-09

  • Orthodontic metal band

LEONE SPA - 08033707016854

CALIBRA 1ST MOLAR BANDS n.LR 9
LEONE SPA
E1600-09
In Commercial Distribution

  • 08033707016854 ()
E1600-09

  • Orthodontic metal band

LEONE SPA - 08033707010579

CALIBRA 1ST MOLAR BANDS n.UL 9
LEONE SPA
E1305-09
In Commercial Distribution

  • 08033707010579 ()
E1305-09

  • Orthodontic metal band

LEONE SPA - 08033707009825

CALIBRA 1ST MOLAR BANDS n.UL 9
LEONE SPA
E1300-09
In Commercial Distribution

  • 08033707009825 ()
E1300-09

  • Orthodontic metal band

LEONE SPA - 08033707009467

CALIBRA 1ST MOLAR BANDS n.UR 9
LEONE SPA
E1205-09
In Commercial Distribution

  • 08033707009467 ()
E1205-09

  • Orthodontic metal band

LEONE SPA - 08033707008712

CALIBRA 1ST MOLAR BANDS n.UR 9
LEONE SPA
E1200-09
In Commercial Distribution

  • 08033707008712 ()
E1200-09

  • Orthodontic metal band

LEONE SPA - 08033707032564

WEB 1ST MOLAR BANDS n.LR 9
LEONE SPA
E8605-09
In Commercial Distribution

  • 08033707032564 ()
E8605-09

  • Orthodontic metal band

LEONE SPA - 08033707028222

WEB 1ST MOLAR BANDS n.UL 9
LEONE SPA
E8300-09
In Commercial Distribution

  • 08033707028222 ()
E8300-09

  • Orthodontic metal band

LEONE SPA - 08033707033530

WEB 1ST MOLAR BANDS n.LL 9
LEONE SPA
E8705-09
In Commercial Distribution

  • 08033707033530 ()
E8705-09

  • Orthodontic metal band

LEONE SPA - 08033707032885

WEB 1ST MOLAR BANDS n.LL 9
LEONE SPA
E8700-09
In Commercial Distribution

  • 08033707032885 ()
E8700-09

  • Orthodontic metal band

LEONE SPA - 08033707031918

WEB 1ST MOLAR BANDS n.LR 9
LEONE SPA
E8600-09
In Commercial Distribution

  • 08033707031918 ()
E8600-09

  • Orthodontic metal band

LEONE SPA - 08033707028871

WEB 1ST MOLAR BANDS n.UL 9
LEONE SPA
E8305-09
In Commercial Distribution

  • 08033707028871 ()
E8305-09

  • Orthodontic metal band

Novel - 00190376076492

Novel-XS Trial, L-5, 9 mm, Tapered
ALPHATEC SPINE, INC.
64797-109-11
In Commercial Distribution

  • 00190376076492 ()

  • Width: 20 Millimeter
  • Length: 18 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial

Novel - 00190376076423

Novel-XS Trial, L, 9 mm, Tapered
ALPHATEC SPINE, INC.
64797-009-11
In Commercial Distribution

  • 00190376076423 ()

  • Length: 18 Millimeter
  • Width: 20 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial

Novel - 00190376076355

Novel-XS Trial, M-5, 9 mm, Tapered
ALPHATEC SPINE, INC.
64795-109-11
In Commercial Distribution

  • 00190376076355 ()

  • Height: 9 Millimeter
  • Width: 17 Millimeter
  • Length: 15 Millimeter


  • Spinal implant trial

Novel - 00190376076287

Novel-XS Trial, M, 9 mm, Tapered
ALPHATEC SPINE, INC.
64795-009-11
In Commercial Distribution

  • 00190376076287 ()

  • Height: 9 Millimeter
  • Width: 17 Millimeter
  • Length: 15 Millimeter


  • Spinal implant trial

Novel - 00190376076218

Novel-XS Trial, S-5, 9 mm, Tapered
ALPHATEC SPINE, INC.
64793-109-11
In Commercial Distribution

  • 00190376076218 ()

  • Length: 12 Millimeter
  • Width: 14 Millimeter
  • Height: 9 Millimeter


  • Spinal implant trial

Novel - 00190376076140

Novel-XS Trial, S, 9 mm, Tapered
ALPHATEC SPINE, INC.
64793-009-11
In Commercial Distribution

  • 00190376076140 ()

  • Height: 9 Millimeter
  • Width: 14 Millimeter
  • Length: 12 Millimeter


  • Spinal implant trial

T-LIFT® - 00190361037743

25mm T-LIFT Straight Trial, 9 mm
SPINEFRONTIER, INC.
SI02861-02
In Commercial Distribution

  • 00190361037743 ()


  • Polymeric spinal interbody fusion cage

T-LIFT® - 00190361037637

25mm T-LIFT Lordotic Trial, 9 mm
SPINEFRONTIER, INC.
SI02862-02
In Commercial Distribution

  • 00190361037637 ()


  • Polymeric spinal interbody fusion cage

TC-100 - 03596010177599

SEMI-TUBULAR PLATE 9 HOLE X 151MM
Smith & Nephew, Inc.
71141309
In Commercial Distribution

  • 03596010177599 ()
71141309

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

SYNERGY - 03596010410481

SYNERGY CEMENTED FEMORAL COMPONENT SIZE 9
Smith & Nephew, Inc.
71316009
In Commercial Distribution

  • 03596010410481 ()
71316009

  • Ceramic femoral head prosthesis
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