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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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Viscoelastic surgical aid
ALTACOR LIMITED
version 1
In Commercial Distribution

  • 15060156070380 ()
  • 15060156070373 ()

  • Total Volume: 1 Milliliter
  • Device Size Text, specify: 1 ml of Biolon solution in prefilled syringe
62501

  • Vitreous/aqueous humour replacement medium, intraoperative
Lithium Manganese Dioxide battery for replacement in Philips(TM) HeartStart(TM) FR2 and FR2+
AED BATTERY EXCHANGE, LLC
3863-ABE
In Commercial Distribution

  • 00864312000215 ()


  • Primary battery
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-27/29
In Commercial Distribution

  • 00851788001549 ()

  • Outer Diameter: 27 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 29 Millimeter
ONXAAP-27/29

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-25
In Commercial Distribution

  • 00851788001532 ()

  • Outer Diameter: 25 Millimeter
ONXAAP-25

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-23
In Commercial Distribution

  • 00851788001525 ()

  • Outer Diameter: 23 Millimeter
ONXAAP-23

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-21
In Commercial Distribution

  • 00851788001518 ()

  • Outer Diameter: 21 Millimeter
ONXAAP-21

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
ON-X LIFE TECHNOLOGIES, INC.
ONXAAP-19
In Commercial Distribution

  • 00851788001501 ()

  • Outer Diameter: 19 Millimeter
ONXAAP-19

  • Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals. The product is packaged in a one syringe pack.
FIDIA FARMACEUTICI SPA
89122-0496-01
In Commercial Distribution

  • M713891220496010 ()

  • Total Volume: 3 Milliliter
89122-0496-01

  • Synovial fluid supplementation medium
Exhaust Collection Bag, S1 (single bag in pouch with IFU), accessory to Cerene Cryotherapy Device
CHANNEL MEDSYSTEMS, INC.
FGS-7015
In Commercial Distribution

  • 00850008595042 ()


  • General cryosurgical system, cryogen gas, electronic
Lithium Manganese Dioxide battery for replacement in Philips(TM) Heartstart(TM) FRx Onsite & Home(TM).
AED BATTERY EXCHANGE, LLC
5070-ABE
In Commercial Distribution

  • 00864312000208 ()


  • Primary battery
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