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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 - 00816127025181

Medial/Lateral Compaction Broach, Size 9
NEXTSTEP ARTHROPEDIX, LLC
10-80-0509
In Commercial Distribution

  • 00816127025181 ()


  • Orthopaedic broach

iNSitu Total Hip System - 00816127024870

Cemented Femoral Stem, Size 9, Lateralized
NEXTSTEP ARTHROPEDIX, LLC
10-16-0009
In Commercial Distribution

  • 00816127024870 ()


  • Uncoated hip femur prosthesis, modular

iNSitu Total Hip System - 00816127024726

Cemented Femoral Stem, Size 9, Standard
NEXTSTEP ARTHROPEDIX, LLC
10-15-0009
In Commercial Distribution

  • 00816127024726 ()


  • Uncoated hip femur prosthesis, modular

Anatomic Shoulder Prosthesis - 07630040706032

Standard Humeral Diaphysis – Cementless, Size 9
Medacta International SA
04.01.0004
In Commercial Distribution

  • 07630040706032 ()


  • Total shoulder prosthesis

Surgical Direct - B382SD9146531320

9” Cone Ring Curette, 8mm, Angled
Surgical Direct, Inc.
SD914653132
In Commercial Distribution

  • B382SD9146531320 ()
SD914653132

  • Bone curette, reusable

Surgical Direct - B382SD9146531110

9” Cone Ring Curette, Straight, 6mm
Surgical Direct, Inc.
SD914653111
In Commercial Distribution

  • B382SD9146531110 ()
SD914653111

  • Bone curette, reusable

Surgical Direct - B382SD9146344000

9” Bruns Curette, Straight Size 00000
Surgical Direct, Inc.
SD914634400
In Commercial Distribution

  • B382SD9146344000 ()
SD914634400

  • Bone curette, reusable

Surgical Direct - B382SD9146343030

9" Bruns Curette, Straight, Size 6
Surgical Direct, Inc.
SD914634303
In Commercial Distribution

  • B382SD9146343030 ()
SD914634303

  • Bone curette, reusable

Surgical Direct - B382SD9144821500

9" Lambotte Osteotome Straight, 15mm Blade
Surgical Direct, Inc.
SD914482150
In Commercial Distribution

  • B382SD9144821500 ()
SD914482150

  • Orthopaedic osteotome

Surgical Direct - B382SDM435080

9 inch Bruns Curette, Size 5
Surgical Direct, Inc.
SDM43508
In Commercial Distribution

  • B382SDM435080 ()
SDM43508

  • Bone curette, reusable

Surgical Direct - B382SDM435060

9 inch Bruns Curette, Size 3
Surgical Direct, Inc.
SDM43506
In Commercial Distribution

  • B382SDM435060 ()
SDM43506

  • Bone curette, reusable

Surgical Direct - B382SDM435040

9 inch Bruns Curette, Size 1
Surgical Direct, Inc.
SDM43504
In Commercial Distribution

  • B382SDM435040 ()
SDM43504

  • Bone curette, reusable

Surgical Direct - B382SD99238561000

Schluger Periodontal File, Fig. 9/10
Surgical Direct, Inc.
SD9923856100
In Commercial Distribution

  • B382SD99238561000 ()
SD9923856100

  • Callous file/rasp, reusable

Defend - 00816577022600

STERI-POUCHES 9" x 15" 200/BOX
YOUNG MYDENT, LLC
SP-9800
In Commercial Distribution

  • 00816577022600 ()
SP-9800

  • Sterilization packaging, single-use

NA - 00816576023035

Shigella dysenteriae type 9 antisera, 2ml
HARDY DIAGNOSTICS
294975
Not in Commercial Distribution

  • 00816576023035 ()
294975

  • Multiple Shigella species antigen IVD, reagent

NA - 00816576022649

Shigella boydii type 9 antisera, 2ml
HARDY DIAGNOSTICS
295293
Not in Commercial Distribution

  • 00816576022649 ()
295293

  • Multiple Shigella species antigen IVD, reagent

Surgical Direct - B382SD929314100

Dental Explorer Figure 9, Round Handle
Surgical Direct, Inc.
SD92931410
In Commercial Distribution

  • B382SD929314100 ()
SD92931410

  • Dental elevator, tooth/root

Surgical Direct - B382SD922615230

9 inch Dandy Nerve Hook, Straight
Surgical Direct, Inc.
SD92261523
In Commercial Distribution

  • B382SD922615230 ()
SD92261523

  • Self-retaining surgical retractor, reusable

Surgical Direct - B382SD922609410

9" Scoville Nerve Hook, 8mm Straight
Surgical Direct, Inc.
SD92260941
In Commercial Distribution

  • B382SD922609410 ()
SD92260941

  • Bone lever/elevator, reusable

Spine Instruments - 07630040792493

Shaver with double blade 9 mm
Medacta International SA
03.22.10.1213
In Commercial Distribution

  • 07630040792493 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040765329

Trial tibial insert # 5 9 mm
Medacta International SA
02.02.10.0098
In Commercial Distribution

  • 07630040765329 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040765282

Trial tibial insert # 4 9 mm
Medacta International SA
02.02.10.0094
In Commercial Distribution

  • 07630040765282 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040765244

Trial tibial insert # 3 9 mm
Medacta International SA
02.02.10.0090
In Commercial Distribution

  • 07630040765244 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630040765190

Trial tibial insert # 2 9 mm
Medacta International SA
02.02.10.0086
In Commercial Distribution

  • 07630040765190 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

HIP Instruments - 07630040760751

SMS Solid manual broach size 9
Medacta International SA
01.36.10.0159
In Commercial Distribution

  • 07630040760751 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

iSmile - 00816419020375

Sterilization Pouch 3-1/2" x 9"
Ismile Dental Products, Inc.
45-2505
In Commercial Distribution

  • 20816419020379 ()
  • 00816419020375 ()
45-2505

  • Sterilization packaging, single-use

iSmile - 00816419020351

Sterilization Pouch 2-3/4" x 9"
Ismile Dental Products, Inc.
45-2503
In Commercial Distribution

  • 20816419020355 ()
  • 00816419020351 ()
45-2503

  • Sterilization packaging, single-use

DJO SURGICAL - 00888912091541

REVELATION 80mm BROACH SZ 9 RT
DJO, LLC
803-04-093
In Commercial Distribution

  • 00888912091541 ()


  • Orthopaedic broach

DJO SURGICAL - 00888912091534

REVELATION 80mm BROACH SZ 9 LT
DJO, LLC
803-04-092
In Commercial Distribution

  • 00888912091534 ()


  • Orthopaedic broach

DJO SURGICAL - 00888912090575

HIP, INSTRUMENT, LINEAR BROACH, SZ 9
Encore Medical, L.P.
803-03-066
In Commercial Distribution

  • 00888912090575 ()


  • Orthopaedic broach
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