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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No Description
W.H. Holden, Inc.
30-0117
In Commercial Distribution

  • D9283001170 ()


  • Dental surgical scissors
No Description
W.H. Holden, Inc.
13-0083
In Commercial Distribution

  • D9281300830 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
No Description
W.H. Holden, Inc.
13-0078
In Commercial Distribution

  • D9281300780 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
No Description
W.H. Holden, Inc.
13-0028-2
In Commercial Distribution

  • D92813002820 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
No Description
W.H. Holden, Inc.
13-0022
In Commercial Distribution

  • D9281300220 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
No Description
W.H. Holden, Inc.
20-0003
In Commercial Distribution

  • D9282000030 ()


  • Bone awl, reusable
Multidil 7 (2PK) - CENTAUR - CAL - 2x5mL
Siemens Healthcare Diagnostics Inc.
10309947
Not in Commercial Distribution

  • 00630414175270 ()
  • 00630414003139 ()
110318

  • Buffered sample diluent IVD
2de14 2-0 Pdo 7 X7
Surgical Specialties México, S. de R.L. de C.V.
RA-1016Q
In Commercial Distribution

  • 10848782018595 ()
  • 00848782018598 ()

  • 2-0 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
2de12 2-0 Pdo 7 X7
Surgical Specialties México, S. de R.L. de C.V.
RA-1007Q
In Commercial Distribution

  • 10848782018465 ()
  • 00848782018468 ()

  • 2-0 USP


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid) and pH.
Siemens Healthcare Diagnostics Inc.
10326145
In Commercial Distribution

  • 00630414549040 ()
  • 00630414009582 ()
A2165C16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
7 day silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20341
In Commercial Distribution

  • 00040565122038 ()
  • 05000223455606 ()
  • 30040565122039 ()
20341

  • Wound-nonadherent dressing, absorbent, antimicrobial
7 day silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20241
In Commercial Distribution

  • 00040565121451 ()
  • 05000223449940 ()
  • 30040565121452 ()
20241

  • Wound-nonadherent dressing, absorbent, antimicrobial
7 day silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20141
In Commercial Distribution

  • 00040565121376 ()
  • 05000223449919 ()
  • 30040565121377 ()
20141

  • Wound-nonadherent dressing, absorbent, antimicrobial
No Description
Silipos Holding LLC
14475
In Commercial Distribution

  • 00614464144752 ()


  • External limb prosthesis socket liner
7 MM V Splitter. 12"
SYMMETRY MEDICAL INC.
10-013-400-1500
In Commercial Distribution

  • 00847538006261 ()
2011-03-034

  • Orthopaedic chisel
7 MM Reverse Curette, 12"
SYMMETRY MEDICAL INC.
10-014-400-1500
In Commercial Distribution

  • 00847538006230 ()
2011-03-035

  • Bone curette, reusable
KIT, EASYSAMPLER, SUCROSE, 7T
QUINTRON INSTRUMENT COMPANY, INC.
QT04214
In Commercial Distribution

  • 00850010197135 ()
QT04214

  • Breath specimen container IVD
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-S00R4
In Commercial Distribution

  • 00849405001607 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S1010-4
In Commercial Distribution

  • 00849405000549 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S2525-4
In Commercial Distribution

  • 00849405011491 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S2025-4
In Commercial Distribution

  • 00849405011484 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S2020-4
In Commercial Distribution

  • 00849405011477 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S1530-4
In Commercial Distribution

  • 00849405011460 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S1520-4
In Commercial Distribution

  • 00849405011453 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S1515-4
In Commercial Distribution

  • 00849405011446 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S1040-4
In Commercial Distribution

  • 00849405011439 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S1030-4
In Commercial Distribution

  • 00849405011422 ()


  • Negative-pressure wound therapy system, electric, single-use
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-S1020-4
In Commercial Distribution

  • 00849405011415 ()


  • Negative-pressure wound therapy system, electric, single-use
Clone R284
NOVODIAX, INC.
K32015-015
Not in Commercial Distribution

  • 00850000596153 ()

  • Total Volume: 15 Milliliter
K32015-015

  • Cytokeratin IVD, kit, enzyme immunohistochemistry
Clone R284
NOVODIAX, INC.
K32015-005
Not in Commercial Distribution

  • 00850000596146 ()

  • Total Volume: 5 Milliliter
K32015-005

  • Cytokeratin IVD, kit, enzyme immunohistochemistry
No Description
BONART CO., LTD.
73120185
In Commercial Distribution

  • 04719873120185 ()


  • Electrosurgical system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-591-007
In Commercial Distribution

  • 09348215134846 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0007
In Commercial Distribution

  • 09348215134587 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0107
In Commercial Distribution

  • 09348215134716 ()


  • Coated hip femur prosthesis, modular
A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
ENZTEC LIMITED
4252-2354
In Commercial Distribution

  • 09421028118811 ()
4252-2354

  • Orthopaedic implant impactor, reusable
Black, Platinum Detail - CP1000
COCHLEAR LIMITED
Z482005
In Commercial Distribution

  • 09321502039918 ()
Z482005

  • Cochlear implant/auditory brainstem implant sound processor
Brown - CP1000
COCHLEAR LIMITED
Z482006
In Commercial Distribution

  • 09321502039901 ()
Z482006

  • Cochlear implant/auditory brainstem implant sound processor
Grey - CP1000
COCHLEAR LIMITED
Z482007
In Commercial Distribution

  • 09321502039895 ()
Z482007

  • Cochlear implant/auditory brainstem implant sound processor
Sand - CP 1000
COCHLEAR LIMITED
Z482008
In Commercial Distribution

  • 09321502039888 ()
Z482008

  • Cochlear implant/auditory brainstem implant sound processor
Black, Golden Detail - CP1000
COCHLEAR LIMITED
Z482009
In Commercial Distribution

  • 09321502039871 ()
Z482009

  • Cochlear implant/auditory brainstem implant sound processor
White - CP1000
COCHLEAR LIMITED
Z544559
In Commercial Distribution

  • 09321502039864 ()
Z544559

  • Cochlear implant/auditory brainstem implant sound processor
6 cm (2 1/2")
COCHLEAR LIMITED
P789746
In Commercial Distribution

  • 09321502039086 ()

  • Length: 6 Centimeter
  • 6 cm long cable
P789746

  • Cochlear implant/auditory brainstem implant coil
8 cm (3")
COCHLEAR LIMITED
P789747
In Commercial Distribution

  • 09321502039079 ()

  • Length: 8 Centimeter
  • 8 cm long cable
P789747

  • Cochlear implant/auditory brainstem implant coil
Conformity stem, high offset, #7
UNITED ORTHOPEDIC CORP.
1110-3207
In Commercial Distribution

  • 04711605583343 ()
1110-3207

  • Metal-on-polyethylene total hip prosthesis
  • Revision coated hip femur prosthesis
  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-16-0335
In Commercial Distribution

  • 09348215046347 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-15-0044
In Commercial Distribution

  • 09348215056933 ()


  • Orthopaedic implant aiming/guiding block, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-607
In Commercial Distribution

  • 09348215056186 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-34-1007
In Commercial Distribution

  • 09348215056056 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-42-3007
In Commercial Distribution

  • 09348215083397 ()


  • Surgical implant template, reusable
No Description
Drägerwerk AG & Co. KGaA
MP02745
Not in Commercial Distribution

  • 04048675389682 ()


  • Anaesthesia breathing circuit, single-use
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