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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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Dakota ACDF System - 00840019941709

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

  • 00840019941709 ()
71-RS-7610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941587

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

  • 00840019941587 ()
71-RS-0610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941549

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

  • 00840019941549 ()
71-RS-0410

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941501

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

  • 00840019941501 ()
71-TN-7810

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941464

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

  • 00840019941464 ()
71-TN-7610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941426

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

  • 00840019941426 ()
71-TN-7410

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941389

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

  • 00840019941389 ()
71-TN-0810

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941341

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

  • 00840019941341 ()
71-TN-0610

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941303

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

  • 00840019941303 ()
71-TN-0410

  • Orthopaedic surgical procedure kit, non-medicated, reusable

PolyMem - 10735471024992

#9 VariSite PolyMem Silicone Border Dressing
FERRIS MFG. CORP.
Silicone Border
In Commercial Distribution

  • 20735471024999 ()
  • 10735471024992 ()
  • 30735471024996 ()

  • 5 in. x 5.1 in.
2499

  • Wound-nonadherent dressing, absorbent, non-antimicrobial

BIORCI - 03596010426277

9 X 35 MM BIORCI SCREW
Smith & Nephew, Inc.
7207565
In Commercial Distribution

  • 03596010426277 ()
7207565

  • Bioabsorbable orthopaedic bone screw

BIORCI - 03596010426260

9 X 30 MM BIORCI SCREW
Smith & Nephew, Inc.
7207564
In Commercial Distribution

  • 03596010426260 ()
7207564

  • Bioabsorbable orthopaedic bone screw

BIORCI - 03596010426253

9 X 25 MM BIORCI SCREW
Smith & Nephew, Inc.
7207563
In Commercial Distribution

  • 03596010426253 ()
7207563

  • Bioabsorbable orthopaedic bone screw

SYNERGY - 03596010410481

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

  • 03596010410481 ()
71316009

  • Ceramic femoral head prosthesis

ARROW - 10801902132823

MAC KIT: 2-L 9 FR DISTAL
TELEFLEX INCORPORATED
IPN037793
In Commercial Distribution

  • 20801902132820 ()
  • 10801902132823 ()
ASK-11142-JHL1

  • Vascular catheter introduction set, nonimplantable

Conquest FX - 03596010404848

CONQUEST FX FEMORAL COMPONENT SIZE 9
Smith & Nephew, Inc.
71316509
In Commercial Distribution

  • 03596010404848 ()
71316509

  • Ceramic femoral head prosthesis

BTT - 08033959221730

bone-marrow trasplantation needle 11G 9 cm
STERYLAB SRL
BTT
In Commercial Distribution

  • 18033959221737 ()
  • 08033959221730 ()
BTT1109

  • Bone marrow biopsy procedure kit

TC-100 - 03596010300461

CLOVERLEAF PLATE 184MM 9 HOLE STERILE
Smith & Nephew, Inc.
71140629
In Commercial Distribution

  • 03596010300461 ()
71140629

  • Orthopaedic fixation plate, non-bioabsorbable

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 - 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

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 - 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

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

ACUFEX - 03596010091635

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

  • 03596010091635 ()
013662

  • General internal orthopaedic fixation system implantation kit

VITROS - 10758750005031

VITROS Chemistry Products Calibrator Kit 9
ORTHO-CLINICAL DIAGNOSTICS, INC.
8568040
In Commercial Distribution

  • 10758750005031 ()
8568040

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

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

Anmuth Medical International - 08403207280930

METZENBAUM Scss Str TC 23cm/9"
Anmuth Medical International, LLC
11-280-23TC
In Commercial Distribution

  • 08403207280930 ()

  • Length: 9 Inch
11-280-23TC

  • General-purpose surgical scissors, reusable

Anmuth Medical International - 08403207161734

MAYO Scss Cvd TC 23cm/9"
Anmuth Medical International, LLC
11-161-23TC
In Commercial Distribution

  • 08403207161734 ()

  • Length: 9 Inch
11-161-23TC

  • General-purpose surgical scissors, reusable

Anmuth Medical International - 08403207007773

LAMBOTTE Osteotome Cvd 38mm 23cm/9"
Anmuth Medical International, LLC
38-651-38
In Commercial Distribution

  • 08403207007773 ()

  • Length: 9 Inch
38-651-38

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007766

LAMBOTTE Osteotome Cvd 30mm 23cm/9"
Anmuth Medical International, LLC
38-651-30
In Commercial Distribution

  • 08403207007766 ()

  • Length: 9 Inch
38-651-30

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007759

LAMBOTTE Osteotome Cvd 25mm 23cm/9"
Anmuth Medical International, LLC
38-651-25
In Commercial Distribution

  • 08403207007759 ()

  • Length: 9 Inch
38-651-25

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007742

LAMBOTTE Osteotome Cvd 18mm 23cm/9"
Anmuth Medical International, LLC
38-651-18
In Commercial Distribution

  • 08403207007742 ()

  • Length: 9 Inch
38-651-18

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007735

LAMBOTTE Osteotome Cvd 13mm 23cm/9"
Anmuth Medical International, LLC
38-651-13
In Commercial Distribution

  • 08403207007735 ()

  • Length: 9 Inch
38-651-13

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007728

LAMBOTTE Osteotome Cvd 6mm 23cm/9"
Anmuth Medical International, LLC
38-651-06
In Commercial Distribution

  • 08403207007728 ()

  • Length: 9 Inch
38-651-06

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007711

LAMBOTTE Osteotome Str 38mm 23cm/9"
Anmuth Medical International, LLC
38-650-38
In Commercial Distribution

  • 08403207007711 ()

  • Length: 9 Inch
38-650-38

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007704

LAMBOTTE Osteotome Str 30mm 23cm/9"
Anmuth Medical International, LLC
38-650-30
In Commercial Distribution

  • 08403207007704 ()

  • Length: 9 Inch
38-650-30

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007698

LAMBOTTE Osteotome Str 25mm 23cm/9"
Anmuth Medical International, LLC
38-650-25
In Commercial Distribution

  • 08403207007698 ()

  • Length: 9 Inch
38-650-25

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007681

LAMBOTTE Osteotome Str 20mm 23cm/9"
Anmuth Medical International, LLC
38-650-20
In Commercial Distribution

  • 08403207007681 ()

  • Length: 9 Inch
38-650-20

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007674

LAMBOTTE Osteotome Str 13mm 23cm/9"
Anmuth Medical International, LLC
38-650-13
In Commercial Distribution

  • 08403207007674 ()

  • Length: 9 Inch
38-650-13

  • Orthopaedic osteotome

Anmuth Medical International - 08403207007667

LAMBOTTE Osteotome Str 6mm 23cm/9"
Anmuth Medical International, LLC
38-650-06
In Commercial Distribution

  • 08403207007667 ()

  • Length: 9 Inch
38-650-06

  • Orthopaedic osteotome

Anmuth Medical International - 08403207006417

ECHLIN Bone Rongeur 4mm 23cm/9"
Anmuth Medical International, LLC
38-259-23
In Commercial Distribution

  • 08403207006417 ()

  • Length: 9 Inch
38-259-23

  • Orthopaedic joint/limb rongeur

Anmuth Medical International - 08403207006400

ECHLIN Bone Rongeur 3mm 23cm/9"
Anmuth Medical International, LLC
38-258-23
In Commercial Distribution

  • 08403207006400 ()

  • Length: 9 Inch
38-258-23

  • Orthopaedic joint/limb rongeur

Anmuth Medical International - 08403207006394

ECHLIN Bone Rongeur 2mm 23cm/9"
Anmuth Medical International, LLC
38-257-23
In Commercial Distribution

  • 08403207006394 ()

  • Length: 9 Inch
38-257-23

  • Orthopaedic joint/limb rongeur
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