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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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AADCO - 00840348528381

X-1 RADIATION RESISTANT GLOVES SIZE 9
AADCO MEDICAL, INC.
LP-212E
In Commercial Distribution

  • 00840348528381 ()
LP-212E

  • Partial-hand radiation shield

Bone Impactor - 10840199500489

Bone Impactor 9 x 12mm tip
KOROS U.S.A., INC.
7224-30
In Commercial Distribution

  • 10840199500489 ()
  • 00840199500482 ()

  • 9x12mm
7224-30

  • External spinal fixation system

Simpact Tri-Fin - 00190837063337

Anterior Curette #1 Ang 9" Handle
Life Spine, Inc.
710-1801-1
In Commercial Distribution

  • 00190837063337 ()
710-1801-1

  • Bone curette, reusable

SURGYCO - 10850049784457

Abdominal Pad (ABD) 5" x 9"
Surgyco LLC
GS001500
In Commercial Distribution

  • 20850049784454 ()
  • 10850049784457 ()
  • 00850049784450 ()


  • General-purpose syringe, single-use

NA - 04042409192449

Cortical Screw 1.5, self-tapping, L 9
aap Implantate AG
SK 1510-09-2
In Commercial Distribution

  • 04042409192449 ()
SK 1510-09-2

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

NA - 04042409192302

Cortical Screw 1.5, self-tapping, L 9
aap Implantate AG
SK 1510-09
In Commercial Distribution

  • 04042409192302 ()
SK 1510-09

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

Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™) - 00840996136969

PLI,SHAVER,BULLET,QC,HUDSON,9
Choice Spine, LP
P070-2309
In Commercial Distribution

  • 00840996136969 ()


  • Polymeric spinal interbody fusion cage

TOMCAT™ Cervical Spinal System - 00840996136136

TOMCAT,0P GUIDE,TABS, 9 HEIGHT
Choice Spine, LP
R070-Z109
In Commercial Distribution

  • 00840996136136 ()


  • Polymeric spinal interbody fusion cage

Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™) - 00840996136792

PLI,SHAVER,BULLET,W/HANDLE,9
Choice Spine, LP
P070-2209
In Commercial Distribution

  • 00840996136792 ()


  • Polymeric spinal interbody fusion cage

Choice Spine Lumbar Spacer System (SABRE™, SHARK™, HORNET™, HARPOON™) - 00840996136662

PLI,SHAVER,PADDLE,QC,HUDSON,9
Choice Spine, LP
P070-2109
In Commercial Distribution

  • 00840996136662 ()


  • Polymeric spinal interbody fusion cage

BTT - 08033959221730

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

  • 18033959221737 ()
  • 08033959221730 ()
BTT1109

  • Bone marrow biopsy procedure kit

NORDENT MANUFACTURING INC - 00840018605473

EXPLORER, SE, #9, DL CR HANDLE
NORDENT MANUFACTURING INC
CEEXS9
In Commercial Distribution

  • 00840018605473 ()


  • Dental surgical probe, reusable

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

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 - 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 - 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

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

NORDENT MANUFACTURING INC - 00840018642256

BONE CURETTE MILLER #9, RND DL
NORDENT MANUFACTURING INC
RECSM9
In Commercial Distribution

  • 00840018642256 ()


  • Bone file/rasp, manual, 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

NORDENT MANUFACTURING INC - 00840018643024

PERIOST ELEVATOR DE MOLT #9 DL
NORDENT MANUFACTURING INC
CEEPMO9
In Commercial Distribution

  • 00840018643024 ()


  • Bone lever/elevator, reusable

NORDENT MANUFACTURING INC - 00840018642812

PERIOST ELEVATOR DE MOLT #9 ST
NORDENT MANUFACTURING INC
EPMO9
In Commercial Distribution

  • 00840018642812 ()


  • Bone lever/elevator, reusable

NORDENT MANUFACTURING INC - 00840018642096

SURG CURETTE DE MILLER #9 STD
NORDENT MANUFACTURING INC
CSM9Y
In Commercial Distribution

  • 00840018642096 ()


  • Bone file/rasp, manual, reusable

NORDENT MANUFACTURING INC - 00840018643239

PERIOST ELEVATOR DE MOLT #9 DL
NORDENT MANUFACTURING INC
REEPMO9
In Commercial Distribution

  • 00840018643239 ()


  • Bone lever/elevator, 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

Dakota ACDF System - 00840019941747

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

  • 00840019941747 ()
71-RS-7810

  • Orthopaedic surgical procedure kit, non-medicated, reusable

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 - 00840019941662

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

  • 00840019941662 ()
71-RS-7410

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Dakota ACDF System - 00840019941624

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

  • 00840019941624 ()
71-RS-0810

  • 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

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 - 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 - 08033707010579

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

  • 08033707010579 ()
E1305-09

  • Orthodontic metal band
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