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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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The Ascension® NuGrip® is an uncemented, one-component prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® NuGrip® is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
NUG44310S
In Commercial Distribution

  • 10381780120063 ()
  • M268NUG44310S1 ()

  • 1.019 in L; Size 10 S
NUG-443-10S

  • Metacarpal prosthesis
The Ascension® NuGrip® is an uncemented, one-component prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® NuGrip® is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
NUG44310M
In Commercial Distribution

  • 10381780120056 ()
  • M268NUG44310M1 ()

  • 1.085 in L; Size 10 M
NUG-443-10M

  • Metacarpal prosthesis
The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
PHS44050WW
Not in Commercial Distribution

  • 10381780114574 ()
  • M268PHS44050WW1 ()

  • Size 50
PHS44050WW

  • Metacarpal prosthesis
The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
PHS44040WW
Not in Commercial Distribution

  • 10381780114567 ()
  • M268PHS44040WW1 ()

  • Size 40
PHS44040WW

  • Metacarpal prosthesis
The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
PHS44030WW
Not in Commercial Distribution

  • 10381780114550 ()
  • M268PHS44030WW1 ()

  • Size 30
PHS44030WW

  • Metacarpal prosthesis
The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
PHS44020WW
Not in Commercial Distribution

  • 10381780114543 ()
  • M268PHS44020WW1 ()

  • Size 20
PHS44020WW

  • Metacarpal prosthesis
The Ascension® PyroHemiSphere™ is an uncemented, onecomponent prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® PyroHemiSphere™ is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
PHS44010WW
Not in Commercial Distribution

  • 10381780114536 ()
  • M268PHS44010WW1 ()

  • Size 10
PHS44010WW

  • Metacarpal prosthesis
The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes as well as trains of such pulses. The applied part is galvanic isolated. The stimulator is powered by a combination of USB bus-power and battery power. The host computer must use Microsoft Windows. The stimulator is controlled via a software API that uses a USB connection. A host application can be situated on top of the API and can control the stimulator.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution

  • EBCI11700 ()
1170

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (refer to diagram), designed for use on the Waters WAVES control unit. HOW SUPPLIED: The Waters WCM cassette is wrapped in a sterile wrap, sealed in a polyethylene bag, and is provided STERILE (ethylene oxide) fluid pathway. The Waters WCM cassette is intended for single-use only. CONTENTS: One (1) STERILE Waters WCM disposable cassette. One (1) STERILE Drape.Five (5) STERILE Specimen Tubes
WATERS MEDICAL SYSTEMS, LLC
WCM Kit
Not in Commercial Distribution

  • 3930005014 ()
  • B154W39300050123 ()
3930005.014

  • Kidney donor-organ preservation/transport perfusion set
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141017ND
Not in Commercial Distribution

  • M248141017ND1 ()
  • 10381780048220 ()

  • 17mm diameter
141017ND

  • Subtalar implant, non-bioabsorbable
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