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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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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

Surgical Direct - B382SD914483150

9 inch Lambotte Osteotomes, Curved, 15mm Blade
Surgical Direct, Inc.
SD91448315
In Commercial Distribution

  • B382SD914483150 ()
SD91448315

  • Orthopaedic osteotome

Surgical Direct - B382SD9144831000

9 inch Lambotte Osteotomes, Curved, 10mm Blade
Surgical Direct, Inc.
SD914483100
In Commercial Distribution

  • B382SD9144831000 ()
SD914483100

  • Orthopaedic osteotome

Surgical Direct - B382SD9144830400

9 inch Lambotte Osteotomes, Curved, 4mm Blade
Surgical Direct, Inc.
SD914483040
In Commercial Distribution

  • B382SD9144830400 ()
SD914483040

  • Orthopaedic osteotome

Surgical Direct - B382SD914482380

9 inch Lambotte Osteotome Straight, 38mm Blade
Surgical Direct, Inc.
SD91448238
In Commercial Distribution

  • B382SD914482380 ()
SD91448238

  • Orthopaedic osteotome

Surgical Direct - B382SD914482200

9 inch Lambotte Osteotome Straight, 19mm Blade
Surgical Direct, Inc.
SD91448220
In Commercial Distribution

  • B382SD914482200 ()
SD91448220

  • Orthopaedic osteotome

Surgical Direct - B382SD914482130

9 inch Lambotte Osteotomes, Straight, 13mm Blade
Surgical Direct, Inc.
SD91448213
In Commercial Distribution

  • B382SD914482130 ()
SD91448213

  • Orthopaedic osteotome

Surgical Direct - B382SD914482060

9 inch Lambotte Osteotome Straight, 6mm Blade
Surgical Direct, Inc.
SD91448206
In Commercial Distribution

  • B382SD914482060 ()
SD91448206

  • Orthopaedic osteotome

Surgical Direct - B382SD914482040

9 inch Lambotte Osteotomes, Straight, 4mm Blade
Surgical Direct, Inc.
SD91448204
In Commercial Distribution

  • B382SD914482040 ()
SD91448204

  • Orthopaedic osteotome

Surgical Direct - B382SD9144601020

8 inch Stille Chisel, 9/16 inch
Surgical Direct, Inc.
SD914460102
In Commercial Distribution

  • B382SD9144601020 ()
SD914460102

  • Orthopaedic osteotome

Surgical Direct - B382SD914457380

9 1/2” Hibbs Osteotome, Curved, 38mm
Surgical Direct, Inc.
SD91445738
In Commercial Distribution

  • B382SD914457380 ()
SD91445738

  • Orthopaedic osteotome

Surgical Direct - B382SD914457100

9 1/2" Hibbs Osteotome Curved, 10mm
Surgical Direct, Inc.
SD91445710
In Commercial Distribution

  • B382SD914457100 ()
SD91445710

  • Orthopaedic osteotome

Surgical Direct - B382SD914456310

9 1/2” Hibbs Osteotome, Straight, 26mm
Surgical Direct, Inc.
SD91445631
In Commercial Distribution

  • B382SD914456310 ()
SD91445631

  • Orthopaedic osteotome

Surgical Direct - B382SD914456260

9 1/2” Hibbs Osteotome, Straight, 16mm
Surgical Direct, Inc.
SD91445626
In Commercial Distribution

  • B382SD914456260 ()
SD91445626

  • Orthopaedic osteotome

Surgical Direct - B382SD914456220

9 1/2” Hibbs Osteotome, Straight, 12mm
Surgical Direct, Inc.
SD91445622
In Commercial Distribution

  • B382SD914456220 ()
SD91445622

  • Orthopaedic osteotome

Surgical Direct - B382SD914456200

9 1/2” Hibbs Osteotome, Straight, 10mm
Surgical Direct, Inc.
SD91445620
In Commercial Distribution

  • B382SD914456200 ()
SD91445620

  • Orthopaedic osteotome

Surgical Direct - B382SD9141781210

9 1/4 Hohmann Retractor, 24mm, Sharp
Surgical Direct, Inc.
SD914178121
Not in Commercial Distribution

  • B382SD9141781210 ()
SD914178121

  • Eye muscle hook, reusable

Anatomic Shoulder Prosthesis - 07630040712750

Humeral Anatomical Metaphysis – Cementless, Size 9, 128°
Medacta International SA
04.01.0037
In Commercial Distribution

  • 07630040712750 ()


  • Total shoulder prosthesis

Surgical Direct - B382SDM365380

9 inch Lambotte Osteotome, Straight, 38mm Wide
Surgical Direct, Inc.
SDM36538
In Commercial Distribution

  • B382SDM365380 ()
SDM36538

  • Orthopaedic osteotome

Surgical Direct - B382SDM365300

9 inch Lambotte Osteotome, Straight, 30mm Wide
Surgical Direct, Inc.
SDM36530
In Commercial Distribution

  • B382SDM365300 ()
SDM36530

  • Orthopaedic osteotome

Surgical Direct - B382SDM365250

9 inch Lambotte Osteotome, Straight, 25mm Wide
Surgical Direct, Inc.
SDM36525
In Commercial Distribution

  • B382SDM365250 ()
SDM36525

  • Orthopaedic osteotome
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