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The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The 2-Hole Straight Tarsalis Plate is offered in short and long lengths. The 3-Hole and 10-Hole Straight Plates are included in the system as standard lengths. The 4-Hole Straight Tarsalis Plate is offered in both standard and short lengths. The Crescentic Tarsalis Plate is offered in left and right configurations. The 4-Hole Diamond Plate is available in left and right configurations. The T-Shaped Tarsalis Plates are offered in 4-hole, 5-hole, and 6-hole configurations. The 5-hole designs are provided in straight, left, and right configurations. The 6-hole is only provided in straight configuration. Upon request, the 6-hole, 7-hole and 8-hole T-Shaped Tarsalis Plates are available.
Ascension Orthopedics, Inc.
TARSALISIMP
Not in Commercial Distribution
- M268TARSALISIMP1 ()
- 10381780064572 ()
TARSALISIMP
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
INTRACRANIAL PRESSURE-TEMPERATURE MONITORING KIT
INTEGRA LIFESCIENCES CORPORATION
110-4BT
Not in Commercial Distribution
- M2711104BT1 ()
- 10381780023630 ()
- 0.106 in. (2.71 mm) diameter number 36 Drill Bit with safety stop; 0.050 in. (1.3 mm) diameter Stylet; 4 Fr (1.35 mm diameter) transducer tipped catheter
110-4BT
- Intracerebral sensor catheter, short-term
OLM INTRACRANIAL PRESSURE MONITORING KIT
INTEGRA LIFESCIENCES CORPORATION
110-4B
Not in Commercial Distribution
- 10381780023623 ()
- M2711104B04 ()
- 0.106 in. (2.71 mm) diameter number 36 Drill Bit with safety stop; 0.050 in. (1.3 mm) diameter Stylet; 4 Fr (1.35 mm diameter) transducer tipped catheter
110-4B
- Intracerebral sensor catheter, short-term
154PCS/054PLS - SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis.
154STY - SINGLE USE castable device: Accessory of conical shape.
045CSM - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with standard retention
045CSMSN - DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention
046CSM - DISPOSABLE device used to contain the retentive cap inside the removable prosthesis.
101OTS - Plastic device. Replicate the retentive cap for container.
RHEIN 83 SRL
OT STRATEGY w/S/STEEL HOUSING x USA
098CALUS
- Dental implant suprastructure, permanent, preformed
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® 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 or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals. The product is packaged in a one syringe pack.
FIDIA FARMACEUTICI SPA
89122-0496-01
In Commercial Distribution
- M713891220496010 ()
- Total Volume: 3 Milliliter
89122-0496-01
- Synovial fluid supplementation medium
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
SPN-1005
In Commercial Distribution
- B090SPN10051 ()
- B090SPN10050 ()
- B090SPN10052 ()
SPN-1005
- Torque manipulation device
Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature
ZIEN MEDICAL TECHNOLOGIES, INC.
5X-GW
In Commercial Distribution
- B0905XGW1 ()
- B0905XGW0 ()
- B0905XGW2 ()
5X-GW
- Torque manipulation device
Accell TBM, 5x5 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-550
In Commercial Distribution
- M3860240005501 ()
- 10889981055653 ()
- 5cmx5cm
02-4000-550
- Bone matrix implant, human-derived
Accell TBM, 5x2 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-520
In Commercial Distribution
- M3860240005201 ()
- 10889981055646 ()
- 5cmX2cm
02-4000-520
- Bone matrix implant, human-derived
Anti-PAX-8 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution
- B502BSB21000 ()
BSB 2100
- Paired box protein (PAX) IVD, antibody