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The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901346
In Commercial Distribution
- 00841549107313 ()
- Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901345
In Commercial Distribution
- 00841549107306 ()
- Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901344
In Commercial Distribution
- 00841549107290 ()
- Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901343
In Commercial Distribution
- 00841549107283 ()
- Screw endosteal dental implant, two-piece
The TRU is a self-tapping, double thread screw implant with a micro groove section, manufactured from pure grade 4 titanium. The implant surface is acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, 5.0 mm, and 6.0 mm. The 3.5 mm implants have a Narrow Platform (NP) prosthetic head. The 4.3 mm, 5.0 mm, and the 6.0 mm implants have a Regular Platform (RP) prosthetic head. The TRU implants are prosthetically compatible with the Nobel Biocare® Conical Connection (CC) implant system. They provide for non-rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains the implant in a titanium tube.
STERNGOLD DENTAL LLC
901342
In Commercial Distribution
- 00841549107276 ()
- Screw endosteal dental implant, two-piece
REA108 recognizes human CD197 which is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV) and is also known as CCR7. For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-).
Miltenyi Biotec B.V. & Co. KG
170-081-034
In Commercial Distribution
- 04049934134258 ()
- Assay development analyte-specific reagent IVD
REA546 recognizes the human CD197 antigen, which is also known as CCR7. CD197 is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV). For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-).
Additional information: Clone REA546 displays negligible binding to Fc receptors.
Miltenyi Biotec B.V. & Co. KG
170-081-083
In Commercial Distribution
- 04049934133763 ()
- Assay development analyte-specific reagent IVD
SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 1.8 GBq of Y90 ± 10% (at the time of calibration) in a total of 3 cc water for injection.
Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value.
SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y002
In Commercial Distribution
- 00850014612146 ()
- Total Volume: 3 Milliliter
- Manual brachytherapy source, permanent implant
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection.
Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value.
SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
- Manual brachytherapy source, permanent implant
The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S2525-6
In Commercial Distribution
- 00849405011699 ()
- Negative-pressure wound therapy system, electric, single-use