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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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Titan™ Total Shoulder System The cement pressurizer is used to impact the cement into the prepared hole.
Ascension Orthopedics, Inc.
PRS-0923-073-002
In Commercial Distribution

  • M269PRS09230730021 ()
  • 10381780246688 ()

  • Size M/L; 1.45 in L
PRS-0923-073-002

  • Orthopaedic cement compressor
Titan™ Total Shoulder System The cement pressurizer is used to impact the cement into the prepared hole.
Ascension Orthopedics, Inc.
PRS-0923-073-001
In Commercial Distribution

  • M269PRS09230730011 ()
  • 10381780246671 ()

  • Size XS/S; 1.25 in L
PRS-0923-073-001

  • Orthopaedic cement compressor
Movement® Great Toe System Metatarsal Surface Reamer Sz. 30/40 The Movement Great Toe metatarsal surface reamer is used to compress and/or remove bone to create a cavity of proper shape and size for device press fit.
Ascension Orthopedics, Inc.
MSR-890-30/40
In Commercial Distribution

  • M269MSR89030401 ()
  • 10381780246275 ()

  • Size 30/40; 3.28 in L
MSR8903040

  • Bone-resection orthopaedic reamer, reusable
Insertion Needle
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-4206
In Commercial Distribution

  • M365SC42060 ()

  • 17 cm Length
  • 6.5 in Length
SC-4206

  • Analgesic spinal cord electrical stimulation system
Insertion Needle
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-4205
In Commercial Distribution

  • M365SC42050 ()

  • 13 cm Length
  • 5 in Length
SC-4205

  • Analgesic spinal cord electrical stimulation system
Insertion Needle
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-4200
In Commercial Distribution

  • M365SC42000 ()

  • 4 in Length
  • 10 cm Length
SC-4200

  • Analgesic spinal cord electrical stimulation system
Eccentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft tissue tensioning, maximize stability, increase range of motion and minimize scapular notching.
Ascension Orthopedics, Inc.
GLS096005E
In Commercial Distribution

  • M269GLS096005E1 ()
  • 10381780121664 ()

  • 1.130 in H; Size 5 mm
GLS-0960-05E

  • Reverse shoulder prosthesis head
Concentric Glenosphere is used in the Titan™ Reverse Shoulder System to allow for optimal soft tissue tensioning, maximize stability, increase range of motion and minimize scapular notching.
Ascension Orthopedics, Inc.
GLS096005C
In Commercial Distribution

  • M269GLS096005C1 ()
  • 10381780121640 ()

  • 1.130 in H; Size 5 mm
GLS-0960-05C

  • Reverse shoulder prosthesis head
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.
NUG44330S
In Commercial Distribution

  • 10381780120117 ()
  • M268NUG44330S1 ()

  • 1.195 in L; Size 30 S
NUG-443-30S

  • 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.
NUG44330M
In Commercial Distribution

  • 10381780120100 ()
  • M268NUG44330M1 ()

  • 1.261 in L; Size 30 M
NUG-443-30M

  • Metacarpal prosthesis
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