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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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SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
BIOVENTUS LLC
71564444
In Commercial Distribution

  • 10389130444418 ()
  • M717715644440 ()
  • 20389130444415 ()
  • 30389130444412 ()
  • 40389130444419 ()


  • Synovial fluid supplementation medium
SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-5555-01
Not in Commercial Distribution

  • M717715655554 ()
  • M717715655553 ()
  • M717715655552 ()
  • M717715655550 ()
7156-5555

  • Synovial fluid supplementation medium
SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-4444-1
In Commercial Distribution

  • M717715644440 ()
  • M717715644442 ()
  • M717715644443 ()
  • M717715644444 ()
7156-4444

  • Synovial fluid supplementation medium
The Plasmaflo OP-05W(A) Asahi plasma separator is a medical device intended for the therapeutic separation of plasma from the whole blood in a clinical setting.
ASAHIKASEI MEDICAL MT K.K.
OP-05W(A)
In Commercial Distribution

  • 04537693005365 ()
  • 24537693005369 ()
  • 14537693005362 ()


  • Apheresis system filter, whole blood
Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD AT, and Survivalink Firstsave(TM) 9100, 9110, 9200, 9210, 9200D, and 9210D
AED BATTERY EXCHANGE, LLC
9141-ABE
In Commercial Distribution

  • 00864312000260 ()
9141-ABE

  • Primary battery
The XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient.
Xvivo Perfusion AB
19020
In Commercial Distribution

  • 07350069520074 ()
19020

  • Lung donor-organ preservation/evaluation system lung-interface set
The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only.
REVISION OPTICS, INC.
RD1-1
In Commercial Distribution

  • 10850394006013 ()
  • 20850394006010 ()

  • Diameter
RD1-1

  • Corneal inlay, aperture reducing
SYNVISC (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan A and hylan B polymers made from hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. SYNVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
58468-0090-1
In Commercial Distribution

  • 08437027710056 ()
  • 08437027710032 ()


  • Synovial fluid supplementation medium
The MARGINPROBE System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (less than 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
DILON MEDICAL TECHNOLOGIES LTD
SA0590020
In Commercial Distribution

  • 07290012534058 ()


  • Intraoperative tumour margin analysis probe
SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (eg. diet, fiber therapy, anti-motility medications).
SALIX PHARMACEUTICALS, LTD.
1085003
In Commercial Distribution

  • 00365649850035 ()
  • 10365649850032 ()


  • Anal tissue reconstructive material
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