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Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
HOYA MEDICAL SINGAPORE PTE. LTD.
B3PC (clear), +20.00D
In Commercial Distribution
- 00886158015789 ()
- Posterior-chamber intraocular lens, pseudophakic
Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
HOYA MEDICAL SINGAPORE PTE. LTD.
B3PC (clear), +19.50D
In Commercial Distribution
- 00886158015772 ()
- Posterior-chamber intraocular lens, pseudophakic
DUROLANE is a clear, viscous gel that contains highly purified sodium hyaluronate. This substance acts as a lubricant and shock absorber in the knee joint. DUROLANE 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.
1082020
In Commercial Distribution
- 08437027710001 ()
- Synovial fluid supplementation medium
DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate-
buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.
BIOVENTUS LLC
1082020
In Commercial Distribution
- 00816986020808 ()
- 10816986020805 ()
- 89130-2020-1 ()
1082020
- Synovial fluid supplementation medium
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).
Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228034094 ()
874721
- Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
The Intrathecal Catheter is a sterile, single-piece, radiopaque, silicone catheter with a pre-inserted hydrophilic stiffening stylet that is used to assist in placing the catheter.
Flowonix Medical, Inc.
11823
In Commercial Distribution
- 00810335020099 ()
- Spinal infusion/drainage catheter
Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
12-0610-01
In Commercial Distribution
- 10850009370225 ()
12-0610-01
- Oral/upper respiratory tract specimen collection kit IVD, clinical
Soft tissue bulking agent indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence primarily due to intrinsic sphincter deficiency.
Uroplasty, Inc.
MPQ-2.5
In Commercial Distribution
- 08717591240266 ()
MPQ-2.5
- Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
VISCO-3 (P980044/S027) 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.
VISCO-3 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. VISCO-3 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
00-1111-001-03
In Commercial Distribution
- 04987541301314 ()
- 14987541301311 ()
00-1111-001-03
- Synovial fluid supplementation medium
GenVisc® 850 sodium hyaluronate (P140005) 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 and simple analgesics, e.g., acetaminophen. GenVisc 850 is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. GenVisc 850 is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).
Avanos Medical, Inc.
50653-0006-01
In Commercial Distribution
- 10850653006013 ()
- 00850653006016 ()
- 20850653006010 ()
- Synovial fluid supplementation medium