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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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iNSitu™ Hip System - 00816127028168

Neck Trial, Size 9, Lateral, Dual Taper
NEXTSTEP ARTHROPEDIX, LLC
10-81-0409
In Commercial Distribution

  • 00816127028168 ()


  • Femoral stem prosthesis trial

iNSitu™ Hip System - 00816127027956

Neck Trial, Size 9, Standard, Dual Taper
NEXTSTEP ARTHROPEDIX, LLC
10-81-0309
In Commercial Distribution

  • 00816127027956 ()


  • Femoral stem prosthesis trial

TheRay Collared and Collarless Femoral Stem - 00816127026461

NECK TRIAL, COLLARED STEM, LATERAL, SIZE 9
NEXTSTEP ARTHROPEDIX, LLC
12-81-0109
In Commercial Distribution

  • 00816127026461 ()


  • Femoral stem prosthesis trial

TheRay Collared and Collarless Femoral Stem - 00816127026331

NECK TRIAL, COLLARED STEM, STANDARD, SIZE 9
NEXTSTEP ARTHROPEDIX, LLC
12-81-0009
In Commercial Distribution

  • 00816127026331 ()


  • Femoral stem prosthesis trial

TheRay Collared and Collarless Femoral Stem - 00816127025471

TheRay Collared Femoral Stem, Size 9, Lateralized
NEXTSTEP ARTHROPEDIX, LLC
12-11-0009
In Commercial Distribution

  • 00816127025471 ()


  • Coated femoral stem prosthesis, modular

TheRay Collared and Collarless Femoral Stem - 00816127025341

TheRay Collared Femoral Stem, Size 9, Standard
NEXTSTEP ARTHROPEDIX, LLC
12-10-0009
In Commercial Distribution

  • 00816127025341 ()


  • Coated femoral stem prosthesis, modular

MasterLoc LatPlus - 07630040715812

Cementless Ti Coated LAT PLUS Stem # 9
Medacta International SA
01.39.409
In Commercial Distribution

  • 07630040715812 ()


  • Press-fit hip femur prosthesis, one-piece

Anatomic Shoulder Prosthesis - 07630040712866

Humeral Anatomical Metaphysis – Cementless, Size 9, 142°
Medacta International SA
04.01.0048
In Commercial Distribution

  • 07630040712866 ()


  • Total shoulder prosthesis

Anatomic Shoulder Prosthesis - 07630040712644

Humeral Anatomical Metaphysis – Cementless, Size 9, 135°
Medacta International SA
04.01.0026
In Commercial Distribution

  • 07630040712644 ()


  • Total shoulder prosthesis

Integra® Miltex® - 10381780384694

Composite, 9, GTX, Double-Ended, Tactile Tone™
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
TD9X
Not in Commercial Distribution

  • H834TD9X0 ()
  • 10381780384694 ()
TD9X

  • Dental restoration carver, resin

Integra® Miltex® - 10381780384007

Carver, Thompson 9, Double-Ended, Tactile Tone™
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
TCTH9
Not in Commercial Distribution

  • H834TCTH90 ()
  • 10381780384007 ()
TCTH9

  • Dental wax carver

Arthrex® - 00888867214866

iBalance TKA, Tibial Prep Tray, Size 9
ARTHREX, INC.
AR-623-T9
In Commercial Distribution

  • 00888867214866 ()
AR-623-T9

  • Device sterilization/disinfection container, reusable

Surgical Direct - B382SD9146531400

9 inch Hatt Spoon, 20mm Oval Cup
Surgical Direct, Inc.
SD914653140
In Commercial Distribution

  • B382SD9146531400 ()
SD914653140

  • Bone curette, reusable

Surgical Direct - B382SD9146531000

9 inch Bruns Curette, Angled, Size 0000
Surgical Direct, Inc.
SD914653100
In Commercial Distribution

  • B382SD9146531000 ()
SD914653100

  • Bone curette, reusable

Surgical Direct - B382SD9146343000

9 inch Bruns Curette, Straight, Size 3
Surgical Direct, Inc.
SD914634300
In Commercial Distribution

  • B382SD9146343000 ()
SD914634300

  • Bone curette, reusable

Surgical Direct - B382SD9146342000

9 inch Bruns Curette, Straight, Size 2
Surgical Direct, Inc.
SD914634200
In Commercial Distribution

  • B382SD9146342000 ()
SD914634200

  • Bone curette, reusable

Surgical Direct - B382SD9146341000

9 Inch Bruns Curette, Straight, Size 1
Surgical Direct, Inc.
SD914634100
In Commercial Distribution

  • B382SD9146341000 ()
SD914634100

  • Bone curette, reusable

Surgical Direct - B382SD9146151000

9 inch Spinal Fusion Curette, Size 000000
Surgical Direct, Inc.
SD914615100
In Commercial Distribution

  • B382SD9146151000 ()
SD914615100

  • Bone curette, reusable

Arthrex® - 00888867188006

CR PLUS TIBIAL BEARING, SIZE 9, 14MM
ARTHREX, INC.
AR-503-A914
In Commercial Distribution

  • 00888867188006 ()
  • M150AR503A9141 ()
AR-503-A914

  • Cruciate-retaining total knee prosthesis

Arthrex® - 00888867187986

CR PLUS TIBIAL BEARING, SIZE 9, 12MM
ARTHREX, INC.
AR-503-A912
In Commercial Distribution

  • 00888867187986 ()
  • M150AR503A9121 ()
AR-503-A912

  • Cruciate-retaining total knee prosthesis

Arthrex® - 00888867187962

CR PLUS TIBIAL BEARING, SIZE 9, 10MM
ARTHREX, INC.
AR-503-A910
In Commercial Distribution

  • 00888867187962 ()
  • M150AR503A9101 ()
AR-503-A910

  • Cruciate-retaining total knee prosthesis

Surgical Direct - B382SD914519550

9 1/2 inch Ombredanne Mallet, 550g
Surgical Direct, Inc.
SD91451955
In Commercial Distribution

  • B382SD914519550 ()
SD91451955

  • Surgical mallet

Arthrex® - 00888867187948

CR PLUS TIBIAL BEARING, SIZE 9, 8MM
ARTHREX, INC.
AR-503-A908
In Commercial Distribution

  • 00888867187948 ()
  • M150AR503A9081 ()
AR-503-A908

  • Cruciate-retaining total knee prosthesis

Arthrex® - 00888867187924

iBalance TKA, Modular Tibial Tray, Sz 9
ARTHREX, INC.
AR-513-T9
In Commercial Distribution

  • 00888867187924 ()
  • M150AR513T91 ()
AR-513-T9

  • Uncoated knee tibia prosthesis, metallic

Surgical Direct - B382SD9144930050

9 3/4" Cruciform Screwdriver, Phenolic Handle
Surgical Direct, Inc.
SD914493005
In Commercial Distribution

  • B382SD9144930050 ()
SD914493005

  • Surgical screwdriver, reusable

Surgical Direct - B382SD914483500

9 inch Lambotte Osteotomes, Curved, 50mm Blade
Surgical Direct, Inc.
SD91448350
In Commercial Distribution

  • B382SD914483500 ()
SD91448350

  • Orthopaedic osteotome

Surgical Direct - B382SD914483440

9 inch Lambotte Osteotomes, Curved, 44mm Blade
Surgical Direct, Inc.
SD91448344
In Commercial Distribution

  • B382SD914483440 ()
SD91448344

  • Orthopaedic osteotome

Surgical Direct - B382SD914483380

9 inch Lambotte Osteotomes, Curved, 38mm Blade
Surgical Direct, Inc.
SD91448338
In Commercial Distribution

  • B382SD914483380 ()
SD91448338

  • Orthopaedic osteotome

Surgical Direct - B382SD914483300

9 inch Lambotte Osteotomes, Curved, 30mm Blade
Surgical Direct, Inc.
SD91448330
In Commercial Distribution

  • B382SD914483300 ()
SD91448330

  • Orthopaedic osteotome

Surgical Direct - B382SD914483200

9 inch Lambotte Osteotomes, Curved, 19mm Blade
Surgical Direct, Inc.
SD91448320
In Commercial Distribution

  • B382SD914483200 ()
SD91448320

  • Orthopaedic osteotome
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