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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 fore foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates.
Ascension Orthopedics, Inc.
TFSFOREFTIMP
Not in Commercial Distribution
- M268TFSFOREFTIMP1 ()
- 10381780064589 ()
TFSFOREFTIMP
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 1 x 1.5g Sealant Syringe (Clear), 3 Dispensing Tips
DENTAL TECHNOLOGIES, INC.
401.0303.002
In Commercial Distribution
- D73540103030020 ()
401.0303.002
- Dental pit/fissure sealant
Alpha-Seal® is a light cure resin-based Pit & Fissure Sealant with fluoride. This sealant contains 50% radiopaque nano-sized fillers. The hard setting, wear resistant material has an ideal flowable viscosity for maximum coverage and protection to seal the pits and fissures of teeth suseptible to caries. The syringe needle tips allow for quick and accurate placement of the material. Alpha-Seal® is available in Opaque shade to allow for easy identification during patient examinations and in a Clear shade for patients who wish to have an "invisible" sealant. Kit Contains: 1 x 1.5g Sealant Syringe (Opaque White), 3 Dispensing Tips
DENTAL TECHNOLOGIES, INC.
401.0103.002
In Commercial Distribution
- D73540101030020 ()
401.0103.002
- Dental pit/fissure sealant
Serum Calibrator
CAROLINA LIQUID CHEMISTRIES CORPORATION
28200
Not in Commercial Distribution
- 00817302022261 ()
- Total Volume: 5 Milliliter
- Kit contains 6 ca-5 bottles, 1 reagent package insert and 1 setpoint package insert
28200
- Glucose/ketone/lipid profile IVD, calibrator
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model LN and L. The device description of the Dental Low-speed Handpiece is as following:
The gear ratios of handpieces have various gear ratios (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different at different pressure of air supply; refer to section 2.3 for details.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization).
Guangdong JINME Medical Technology Co., Ltd.
LN, L
In Commercial Distribution
- 06971119540029 ()
- Dental power tool system handpiece, pneumatic
The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only.
STANBIO LABORATORY, L.P.
401010
In Commercial Distribution
- 00657498000090 ()
- 00657498001868 ()
401010
- Single-channel clinical chemistry analyser IVD, point-of-care
laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.
Biolase, Inc.
laserwhite20
In Commercial Distribution
- 00647529000113 ()
- 00647529000281 ()
7400030
- Dental coating, tooth-desensitizing
This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.
Carl Zeiss Meditec AG
VISULAS YAG III
In Commercial Distribution
- 04049471091373 ()
- Laser console (H x W x D) 135mm x 210mm x 330mm
- Ophthalmic solid-state laser system, photodisruption
The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445060
In Commercial Distribution
- 00842768004407 ()
- 00630414009759 ()
CBHCG
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
The HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.
ZEUS SCIENTIFIC, INC.
6401
In Commercial Distribution
- 00845533001335 ()
6401
- Human immunoglobulin G (IgG) murine conjugate antibody reagent IVD