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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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ReShape Lap-Band® 2.0, FLEX & Access Port, Standard
ReShape Lifesciences Inc.
D-3304
In Commercial Distribution

  • 00850007764548 ()

  • Standard
D-3304

  • Gastric band access port kit
ReShape Lap-Band® 2.0 FLEX, Large
ReShape Lifesciences Inc.
D-3365
In Commercial Distribution

  • 00850007764517 ()

  • Large
D-3365

  • Gastric band
ReShape Lap-Band® 2.0 FLEX, Standard
ReShape Lifesciences Inc.
D-3360
In Commercial Distribution

  • 00850007764500 ()

  • Standard
D-3360

  • Gastric band
RapidPort® EZ Access Port Kit (0-14cc) for use with LAP-BAND® AP System Large
ReShape Lifesciences Inc.
C-2306
In Commercial Distribution


  • 0-14cc
C-2306

  • Gastric band access port kit
RapidPort®EZ Access Port Kit (0-10cc) for use with LAP-BAND® AP System Standard
ReShape Lifesciences Inc.
C-2304
In Commercial Distribution


  • 0-10cc
C-2304

  • Gastric band access port kit
LAP-BAND® Access Port Needle 3.5 inch Pouch
ReShape Lifesciences Inc.
B-20301-10
In Commercial Distribution

  • 10850007764330 ()
  • 10811955020411 ()
  • 00850007764333 ()
B-20301-10

  • Subcutaneous infusion/injection port needle
LAP-BAND® Access Port Needle 2 inch Pouch
ReShape Lifesciences Inc.
B-20302-10
In Commercial Distribution

  • 10850007764323 ()
  • 10811955020428 ()
  • 00850007764326 ()
B-20302-10

  • Subcutaneous infusion/injection port needle
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 Optilume® Urethral Drug Coated Balloon (Optilume DCB) Catheter is a 0.038” (0.97 mm) over-the-wire (OTW) guidewire compatible catheter with a dual lumen design and a tapered, atraumatic tip. The Optilume DCB is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter has a semi-compliant inflatable balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel. The drug coating covers the working length of the balloon body. The device has two radiopaque marker bands that indicate the working length of the balloon where the drug coating is applied. The drug coated balloon is covered with a protective sheath that is discarded prior to use.
Urotronic, Inc.
1110
In Commercial Distribution

  • 00853095008334 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 50 Millimeter
  • Balloon Rated Burst Pressure: 12 Atmosphere
1110-06050B

  • Urethral dilatation catheter, drug-eluting
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