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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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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

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

Arthrex® - 00888867344853

REVERS APEX BROACH/TRIAL, SIZE 9
ARTHREX, INC.
AR-9510-09SM
In Commercial Distribution

  • 00888867344853 ()
AR-9510-09SM

  • Orthopaedic broach

Arthrex® - 00888867019256

RETROSCREW, TIBIAL 9 X 20 MM
ARTHREX, INC.
AR-1586RB-09
In Commercial Distribution

  • 00888867019256 ()
  • M150AR1586RB091 ()
AR-1586RB-09

  • Bioabsorbable orthopaedic bone screw

Stealth Surgical - 00888515272484

MICRO KERRISON, 40DEG UP, 9", 4MM
BOSS INSTRUMENTS, LTD., INC.
SS4065
In Commercial Distribution

  • 00888515272484 ()
SS4065

  • Spinal rongeur

Stealth Surgical - 00888515272453

MICRO KERRISON, 40DEG UP, 9", 1.5MM
BOSS INSTRUMENTS, LTD., INC.
SS4062
In Commercial Distribution

  • 00888515272453 ()
SS4062

  • Spinal rongeur

BOSS Instruments - 00888515253124

Bunnell tendon Passers, malleable, 5mm, 9"
BOSS INSTRUMENTS, LTD., INC.
96-5768
In Commercial Distribution

  • 00888515253124 ()
96-5768

  • Tendon/ligament tunneller

BOSS Instruments - 00888515252844

Brand Tendon Fcp, 9 1/2"
BOSS INSTRUMENTS, LTD., INC.
96-5706
In Commercial Distribution

  • 00888515252844 ()
96-5706

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable

BOSS Instruments - 00888515237810

Ombredanne Mallet, 550g, 9 1/2"
BOSS INSTRUMENTS, LTD., INC.
93-0234
In Commercial Distribution

  • 00888515237810 ()
93-0234

  • Surgical mallet

Integra® Miltex® - 10381780510659

Copper Band, Hard, #9 - 100 Pack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
536-52190
Not in Commercial Distribution

  • H834536521901 ()
  • 10381780510659 ()
  • 00381780510652 ()
536-52190

  • Dental impression tray, reusable

Sims Curette - 00888937017434

Sims Curette, size 2: 9 mm
Coopersurgical, Inc.
392-112
In Commercial Distribution

  • 00888937017434 ()

  • Outer Diameter: 9 Millimeter


  • Endometrial biopsy curette

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

Integra® Miltex® - 10381780498285

EndoSolutions® Hornet #9, 25mm-5/Pk
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
EMH259
Not in Commercial Distribution

  • 10381780498285 ()
  • 00381780498288 ()
EMH259

  • Rotary/reciprocating endodontic file/rasp, single-use

Integra® Miltex® - 10381780498193

EndoSolutions® Hornet #9, 21mm-5/Pk
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
EMH219
Not in Commercial Distribution

  • 10381780498193 ()
  • 00381780498196 ()
EMH219

  • Rotary/reciprocating endodontic file/rasp, single-use

Integra® Miltex® - 10381780497929

EndoMagic!® #9, 25mm Files-5/Pack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
EM815-3008
Not in Commercial Distribution

  • 10381780497929 ()
  • 00381780497922 ()
EM815-3008

  • Rotary/reciprocating endodontic file/rasp, single-use

Integra® Miltex® - 10381780497912

EndoMagic!® #9, 21mm Files-5/Pack
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
EM815-3007
Not in Commercial Distribution

  • 10381780497912 ()
  • 00381780497915 ()
EM815-3007

  • Rotary/reciprocating endodontic file/rasp, single-use

MedSource Straps - 00816703028407

Plastic Buckle One Piece 9' White
MEDSOURCE INTERNATIONAL LLC
MS-ST900
In Commercial Distribution

  • 00816703028407 ()
Not Applicable

  • Limb/torso/head restraint, reusable

S-ROM - 10603295145813

S-ROM MI BROACH 9 x 14
DEPUY ORTHOPAEDICS, INC.
2576-08-114
In Commercial Distribution

  • 10603295145813 ()
257608114

  • Orthopaedic broach

SUMMIT - 10603295143031

SUMMIT TAPERED REAMER SIZE 8/9
DEPUY ORTHOPAEDICS, INC.
2570-02-400
In Commercial Distribution

  • 10603295143031 ()
257002400

  • Medullary canal orthopaedic reamer, rigid

ATTUNE - 10603295130833

ATTUNE TIBIAL BASE TRIAL SIZE 9
DEPUY (IRELAND)
2545-00-109
In Commercial Distribution

  • 10603295130833 ()
254500109

  • Knee tibia prosthesis trial, reusable

PROSTALAC - 10603295129684

PROSTALAC TRIAL BALL SIZE 32 + 9
DEPUY ORTHOPAEDICS, INC.
2541-93-320
In Commercial Distribution

  • 10603295129684 ()
254193320

  • Femoral head prosthesis trial

S-ROM - 10603295129448

11/13 S-ROM TRIAL 48mm +9
DEPUY ORTHOPAEDICS, INC.
2531-80-500
In Commercial Distribution

  • 10603295129448 ()
253180500

  • Femoral head prosthesis trial

S-ROM - 10603295129332

11/13 S-ROM TRIAL 44mm +9
DEPUY ORTHOPAEDICS, INC.
2531-65-500
In Commercial Distribution

  • 10603295129332 ()
253165500

  • Femoral head prosthesis trial

S-ROM - 10603295129158

11/13 S-ROM TRIAL 40mm +9
DEPUY ORTHOPAEDICS, INC.
2531-45-500
In Commercial Distribution

  • 10603295129158 ()
253145500

  • Femoral head prosthesis trial

LAMBOTTE - 10603295121282

LAMBOTTE OSTEOTOME INSTRUMENT CASE 9 IN
DEPUY ORTHOPAEDICS, INC.
2395-12-000
In Commercial Distribution

  • 10603295121282 ()
239512000

  • Instrument tray, reusable

DJO SURGICAL - 00888912124492

BUSHING, FEMORAL IM, MI, 9 DEG
Encore Medical, L.P.
800-01-382
In Commercial Distribution

  • 00888912124492 ()


  • Orthopaedic prosthesis implantation positioning instrument, 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
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