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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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EDWARDS EXPANDABLE INTRODUCER SHEATH SET
Edwards Lifesciences LLC
916ES23
In Commercial Distribution

  • 00690103192100 ()

  • 16 FRENCH NOMINAL INTRODUCER SHEATH INNER DIAMETER IS COMPATIBLE WITH THE 23 MM VALVE AND DELIVERY SYSTEM
916ES23A

  • Vascular catheter introduction set, nonimplantable
Orthovisc is injected into the knee joint to cushion and lubricate.
PAVAN TRADING LTD
None
In Commercial Distribution

  • 05060548950026 ()


  • Synovial fluid supplementation medium
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
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
SEIKAGAKU CORPORATION
00-1111-001-00
In Commercial Distribution

  • 04987541300911 ()
00-1111-001-00

  • Synovial fluid supplementation medium
SILIKON™ 1000 (purified polydimethylsiloxane) is highly purified long chain polydimethylsiloxane trimethylsiloxy terminated silicone oil. It is sterile, non-pyrogenic, clear, colorless and has a viscosity of 1000 cs. for use as a post-operative retinal tamponade during vitreoretinal surgery. SILIKON™ 1000 is composed of silicon, oxygen, carbon and hydrogen atoms. SILIKON™ 1000 is immiscible with aqueous components and is relatively inert material with little biological toxicity potential.
Alcon Laboratories, Inc.
8065601187
In Commercial Distribution

  • 00380656011873 ()

  • Total Volume: 8.5 Milliliter


  • Aqueous/vitreous humour replacement medium kit
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
SEIKAGAKU CORPORATION
00-1111-001-00
Not in Commercial Distribution

  • 00087541300912 ()
00-1111-001-00

  • Synovial fluid supplementation medium
Essure is a permanent Birth Control System. Each Essure Kit is comprised of two pouched disposable delivery systems with a wound-down insert and a valved introducer.
Bayer Healthcare LLC
ESS305 (Kit)
Not in Commercial Distribution

  • 20888853003058 ()


  • Fallopian tube occlusion insert, non-biodegradable
NeviFile is a software application that can be installed on a computer, to be used as an accessory to Nevisense. NeviFile is used for printing reports as well as saving reports for viewing. NeviFile is also needed to be able to print reports from Nevisense via network, immediately when an examination iscompleted and a report is created.
Scibase AB
142-0013
In Commercial Distribution

  • 07350094440279 ()
142-0013

  • Neoplasm electrical impedance spectrometer electrode array
Euflexxa is injected into the knee to relieve the pain of osteoarthritis.
PAVAN TRADING LTD
None
In Commercial Distribution

  • 05060548950064 ()


  • Synovial fluid supplementation medium
Supartz is injected into the knee to relieve the pain of osteoarthritis.
PAVAN TRADING LTD
None
In Commercial Distribution

  • 05060548950057 ()


  • Synovial fluid supplementation medium
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