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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Trial Modular Neck #15
LIMACORPORATE SPA
Trial Modular Neck
In Commercial Distribution

  • 08033390065399 ()

  • # 15
9042.50.150

  • Femoral stem prosthesis trial
PRIMA TT Glenoid - K-Wire Positioning Jig Dia. 25 mm 15°
LIMACORPORATE SPA
9019.75.315
In Commercial Distribution

  • 08033390240697 ()

  • 15°
9019.75.315

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Stopper Sleeve for Glenoid Drill – 15°
LIMACORPORATE SPA
9013.75.377
In Commercial Distribution

  • 08033390185103 ()

  • 15°
9013.75.377

  • Orthopaedic prosthesis implantation positioning instrument, reusable
K-wire Positiong Jig - 15°
LIMACORPORATE SPA
9013.75.333
In Commercial Distribution

  • 08033390170178 ()

  • 15°
9013.75.333

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Trial Augmented 630 MB - 15°
LIMACORPORATE SPA
9013.75.993
In Commercial Distribution

  • 08033390167550 ()

  • 15°
9013.75.993

  • Shoulder glenoid fossa prosthesis trial
Sleeve for Angled Glenoid Reamer - 15°
LIMACORPORATE SPA
9013.75.367
In Commercial Distribution

  • 08033390167321 ()

  • 15°
9013.75.367

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Bone Graft Instrument Set - 15° Graft Shaper
LIMACORPORATE SPA
Bone Graft Instrument Set
In Commercial Distribution

  • 08033390109604 ()

  • 15°
9013.75.475

  • Orthopaedic reamer guide
Trial Lateralized Modular Neck #15
LIMACORPORATE SPA
Trial Modular Neck
In Commercial Distribution

  • 08033390065467 ()

  • # 15
9042.51.150

  • Femoral stem prosthesis trial
PRIMA TT Glenoid - Trial Baseplate Full Wedge 15°
LIMACORPORATE SPA
9019.75.915
In Commercial Distribution

  • 08033390241014 ()

  • 15°
9019.75.915

  • Shoulder glenoid fossa prosthesis trial
PRIMA - Cemented Axial reamer #1-5
LIMACORPORATE SPA
9013.67.430
In Commercial Distribution

  • 08033390214537 ()

  • #1-5
9013.67.430

  • Medullary canal orthopaedic reamer, rigid
Bone Graft Instrument Set - 15° Graft Shaper
LIMACORPORATE SPA
Bone Graft Instrument Set
In Commercial Distribution

  • 08033390118323 ()

  • 15°
9013.75.471

  • Orthopaedic reamer guide
No Description
Zimmer, Inc.
SSI005615
In Commercial Distribution

  • 00889024584921 ()

  • 15
SSI005615

  • Femoral stem prosthesis trial
No Description
Zimmer GmbH
01.00296.150
In Commercial Distribution

  • 00889024482326 ()

  • 15


  • Uncoated hip femur prosthesis, modular
CLS Brevius Kinectiv Rasp Size 15
Zimmer GmbH
01.00297.150
In Commercial Distribution

  • 00889024280830 ()

  • 15


  • Bone file/rasp, manual, reusable
CLS Brevius Stem with Kinectiv, Size 15
Zimmer GmbH
01.00296.150
In Commercial Distribution

  • 00889024280694 ()

  • 15


  • Uncoated hip femur prosthesis, modular
No Description
Zimmer GmbH
01.00561.215
In Commercial Distribution

  • 00889024593176 ()

  • 15
01.00561.215

  • Revision uncoated hip femur prosthesis
No Description
Zimmer GmbH
01.00561.315
In Commercial Distribution

  • 00889024593220 ()

  • 15
01.00561.315

  • Revision uncoated hip femur prosthesis
RASP SIZE 15
FX SOLUTIONS
910-0215
In Commercial Distribution

  • 03701037306611 ()

  • 15
910-0215

  • Bone file/rasp, manual, reusable
  • Orthopaedic surgical procedure kit, non-medicated, reusable
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
SIGNUS Medizintechnik GmbH
Curette, rectangular
In Commercial Distribution

  • 04047844059814 ()

  • 15°
SK-0101

  • Orthopaedic surgical procedure kit, non-medicated, reusable
broach
implantcast GmbH
80049015
In Commercial Distribution

  • 04048844196608 ()

  • 15


  • Orthopaedic broach
No Description
Biomet Orthopedics, LLC
9032-08-015
In Commercial Distribution

  • 00887868064326 ()

  • +15
903208015

  • Bone nail end-cap
No Description
Biomet Orthopedics, LLC
8142-35-115
Not in Commercial Distribution

  • 00887868037931 ()

  • +15
814235115

  • Orthopaedic bone screw (non-sliding)
No Description
Biomet Orthopedics, LLC
8142-35-015
Not in Commercial Distribution

  • 00887868037894 ()

  • +15
814235015

  • Orthopaedic bone screw (non-sliding)
No Description
Biomet Orthopedics, LLC
909871
In Commercial Distribution

  • 00887868569036 ()

  • 15°
909871

  • Orthopaedic osteotome
No Description
Biomet Orthopedics, LLC
904804
In Commercial Distribution

  • 00887868567667 ()

  • 15°
904804

  • Bone file/rasp, manual, reusable
No Description
Biomet Orthopedics, LLC
904800
In Commercial Distribution

  • 00887868567643 ()

  • 15°
904800

  • Bone file/rasp, manual, reusable
15mm Modular Inserter
SPINEOLOGY INC.
34-12-11
In Commercial Distribution

  • M7404400040 ()

  • 15
  • Length: 15 Millimeter
440-0040

  • Orthopaedic inorganic implant inserter/extractor, reusable
15mm Rasp
SPINEOLOGY INC.
34-06-17
In Commercial Distribution

  • M7404400034 ()

  • Length: 15 Millimeter
  • 15
440-0034

  • Bone file/rasp, manual, reusable
No Description
edelweiss dentistry products gmbh
13205
In Commercial Distribution

  • 09120046321455 ()


  • Dental veneer, professional
  • Dental composite resin
No Description
edelweiss dentistry products gmbh
13204
In Commercial Distribution

  • 09120046321448 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13203
In Commercial Distribution

  • 09120046321431 ()


  • Dental veneer, professional
  • Dental composite resin
No Description
edelweiss dentistry products gmbh
13105
In Commercial Distribution

  • 09120046321172 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13104
In Commercial Distribution

  • 09120046321165 ()


  • Dental composite resin
  • Dental veneer, professional
No Description
edelweiss dentistry products gmbh
13103
In Commercial Distribution

  • 09120046321158 ()


  • Dental composite resin
  • Dental veneer, professional
Scissors, 15°, double-action , Tube-shaf ValveGate™PRO Ø5 17cm
Geister Medizintechnik GmbH
38-7830S
In Commercial Distribution

  • 04057034132296 ()
38-7830S

  • General-purpose surgical scissors, reusable
Scissors, 15°, double-action , Tube-shaf ValveGate™classic Ø5 17cm
Geister Medizintechnik GmbH
34-7830S
In Commercial Distribution

  • 04057034122976 ()
34-7830S

  • General-purpose surgical scissors, reusable
ISQ Measurement Peg
Osstell AB
Osstell SmartPeg Type 15
In Commercial Distribution

  • 09010522000151 ()
  • 09010522001295 ()
100386

  • Dental implant stability resonance frequency analysis peg
Absorbent Paper Points, 02 Taper 15, 200 Points, P 21
Meta Biomed Co., Ltd.
2845
In Commercial Distribution

  • 08806387828457 ()


  • Endodontic paper point
Flavored Hemostatic retraction solution for topical dental application with 25% aluminum sulfate, 15 mL
PASCAL COMPANY, INC.
15600
In Commercial Distribution

  • 00310866000817 ()
15600

  • Gingival retraction solution
Absorbent Paper Points, 02 Taper 15, 200 Points, P 31R
Meta Biomed Co., Ltd.
2718
In Commercial Distribution

  • 08806387827184 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 15, 200 Points, P 31S
Meta Biomed Co., Ltd.
2606
In Commercial Distribution

  • 08806387826064 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 15, 200 Points, P 61
Meta Biomed Co., Ltd.
2496
In Commercial Distribution

  • 08806387824961 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Taper 15, 120 Points, P 71
Meta Biomed Co., Ltd.
2377
In Commercial Distribution

  • 08806387823773 ()


  • Endodontic paper point
Absorbent Paper Points, 02 Tape15, 200 Points, P 71
Meta Biomed Co., Ltd.
2234
In Commercial Distribution

  • 08806387822349 ()


  • Endodontic paper point
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S0005
In Commercial Distribution

  • 00849405011507 ()


  • Negative-pressure wound therapy system, electric, single-use
Multidil 15 ReadyPack (2PK) - CENTAUR - 2x25 mL
Siemens Healthcare Diagnostics Inc.
11200097
In Commercial Distribution

  • 00630414211015 ()
  • 00630414223513 ()
11200097

  • Buffered sample diluent IVD
No Description
W.H. Holden, Inc.
10-7141
In Commercial Distribution

  • D9281071410 ()


  • Dental suction system cannula, reusable
No Description
W.H. Holden, Inc.
40-0520H
In Commercial Distribution

  • D928400520H0 ()


  • Periotome, reusable
No Description
BIOCARE MEDICAL LLC
PFA7218V
In Commercial Distribution

  • 00847627000569 ()


  • Nucleic acid hybridization detection IVD, probe
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-115
In Commercial Distribution

  • 09348215074784 ()


  • Surgical implant template, reusable
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