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
IRIDEX CORPORATION
65900-H500
In Commercial Distribution

  • 00813125014650 ()


  • General/multiple surgical diode laser system
No Description
Heine Optotechnik GmbH & Co. KG
1LS
In Commercial Distribution

  • 04053755188383 ()
C-215.40.535

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
1LS
In Commercial Distribution

  • 04053755188376 ()
C-215.40.310

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755188222 ()
C-008.33.541

  • Indirect binocular ophthalmoscope
Microdrive Ø25.4mm Holder instrument Rosa Brain 3.0 & One 3.1 Alpha Omega microdrive holder for CRW supplied with2 M5 x 10 wing nut and 1 M4*10 knurled
MEDTECH
174014
In Commercial Distribution

  • 03760244032096 ()
ROSAS00497

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
No Description
IRIDEX CORPORATION
65515-H500
In Commercial Distribution

  • 00813125015626 ()


  • General/multiple surgical diode laser system
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755188239 ()
C-174.40.670

  • Indirect binocular ophthalmoscope
No Description
BIOMET SPINE LLC
129130
In Commercial Distribution

  • 00880304873810 ()

  • 8mm X 30mm Expansive Screw
129130

  • Uncoated femoral stem prosthesis, one-piece
GE Omega V replacement foam table pad long version.UltraCare foam configuration, a soft 4 way stretch cover with a supportive foam core topped with a visco memory foam for added pressure management.
David Scott Company
BB-GEOMVL-UC
In Commercial Distribution

  • 15060797550647 ()

  • Width: 26 Inch
  • Length: 132 Inch
BB-GEOMVL-UC

  • Operating table patient pressure distribution pad, reusable
No Description
IRIDEX CORPORATION
30903-H500
In Commercial Distribution

  • 00813125015619 ()


  • General/multiple surgical diode laser system
Non-Precious Ceramic Alloy
STERNGOLD DENTAL LLC
5052228
Not in Commercial Distribution

  • 00841549100574 ()


  • Dental casting noble alloy
Non-precious Ceramic Alloy
STERNGOLD DENTAL LLC
5012238
Not in Commercial Distribution

  • 00841549100536 ()


  • Dental casting noble alloy
No Description
IRIDEX CORPORATION
13152-H500
In Commercial Distribution

  • 00813125015633 ()


  • General/multiple surgical diode laser system
The iBEAM® evo Extension H&N is designed to support the patient’s head and neck region and extends off the end of the iBEAM® evo Couchtop by 400 mm. The small profile (omega shape) optimizes the access to the treatment area, facilitating the use of complex and non coplanar beam angles.
3C-Medical Intelligence GmbH
P10105-413
In Commercial Distribution

  • 04056719001308 ()
P10105-413

  • Accelerator system table, non-powered
This unit is connected to the NIDEK GREEN LASER DIODE PHOTOCOAGULATOR, Model GYC-1000 (main body) to comprise the photocoagulation system and applied to the treatment of the affected area using the B.I.O. (HEINE OMEGA 180 TYPE). The comprised photocoagulation system makes it possible to select between photocoagulation with the green laser beam (wavelength: 532 nm) and observation with the B.I.O..
NIDEK CO.,LTD.
17120-0000
In Commercial Distribution

  • 04987669100271 ()


  • General/multiple surgical frequency-doubled solid-state laser system
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Double Pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x20 Solid Wound
Not in Commercial Distribution

  • 05694310960328 ()

  • Width: 7 Centimeter
  • Length: 20 Centimeter
50200S21D0D

  • Collagen wound matrix dressing
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Meshed https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x10 Meshed Wound
Not in Commercial Distribution

  • 05694310960304 ()
  • 05694310960298 ()

  • Width: 7 Centimeter
  • Length: 10 Centimeter
50200M03B0D

  • Collagen wound matrix dressing
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Meshed https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x7 Meshed Wound
Not in Commercial Distribution

  • 05694310960281 ()
  • 05694310960274 ()

  • Width: 7 Centimeter
  • Length: 7 Centimeter
50200M04B0D

  • Collagen wound matrix dressing
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
7x7 Fenestrated Wound
Not in Commercial Distribution

  • 05694310960267 ()
  • 05694310960250 ()

  • Width: 7 Centimeter
  • Length: 7 Centimeter
50200M04B0D

  • Collagen wound matrix dressing
"Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Particularized, double pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf"
KERECIS hf.
7x7 Particularized Wound
Not in Commercial Distribution

  • 05694310960977 ()

  • Width: 7 Centimeter
  • Length: 7 Centimeter
50200P04D0D

  • Collagen wound matrix dressing
"Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Particularized, double pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf"
KERECIS hf.
3x7 Fragmented Wound
Not in Commercial Distribution

  • 05694310960960 ()
  • 05694310960953 ()

  • Width: 3 Centimeter
  • Length: 7 Centimeter
50200P02D0D

  • Collagen wound matrix dressing
Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds 14 mm Circular https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf
KERECIS hf.
14 mm Solid Circular Wound
Not in Commercial Distribution

  • 05694310960144 ()
  • 05694310960137 ()

  • Circumference: 14 Millimeter
50200S14B0D

  • Collagen wound matrix dressing
Acellular fish skin for topical and surgical wounds. "Acellular fish skin for topical and surgical wounds. INTENDED USE Kerecis® Omega 3 Wound is indicated for the management of wounds including: •Partial and full-thickness wounds •Pressure ulcers •Venous ulcers •Chronic vascular ulcers •Diabetic ulcers •Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Draining Wounds Particularized, double pouch https://www.kerecis.com/wp-content/uploads/2020/11/Instructions-for-Use-IFU.pdf"
KERECIS hf.
3x3.5 Particularized Wound
Not in Commercial Distribution

  • 05694310960939 ()

  • Width: 3 Centimeter
  • Length: 3.5 Centimeter
50200P01D0D

  • Collagen wound matrix dressing
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