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The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown.
DJO, LLC
OL1000 Single Coil Size 1
In Commercial Distribution
- 00888912161749 ()
01-211-0001
- Patient-worn bone growth electromagnetic stimulator
The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown.
DJO, LLC
OL1000 Single Coil Size 4
In Commercial Distribution
- 00888912161770 ()
01-211-0004
- Patient-worn bone growth electromagnetic stimulator
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146
In Commercial Distribution
- 05060462240029 ()
- Liver donor-organ preservation/transport system
TriVisc™ 850 sodium hyaluronate (P160057) 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 and simple analgesics, e.g., acetaminophen. TriVisc is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) with an average molecular weight of 850,000 daltons and a range of 620,000 – 1,170,000 daltons). The HA is a polymer of repeating disaccharide units of glucuronic acid and N-acetyl-glucosamine derived from a bacterial fermentation process. TriVisc is supplied in a prefilled syringe containing 25 mg of HA in 2.5 mL of physiological saline solution (1% solution).
Avanos Medical, Inc.
50653-0006-04
In Commercial Distribution
- 10850653006044 ()
- 00850653006047 ()
- 20850653006041 ()
- Synovial fluid supplementation medium
No Description
PREMIA SPINE LTD
86818
In Commercial Distribution
- 07290115932904 ()
- Device sterilization/disinfection container, reusable
Adherus AutoSpray Dural Sealant is a sterile, single-use, electromechanical, battery operated, device with internal system components that provide air flow to aid in the delivery of a synthetic, absorbable, two-component hydrogel sealant system and allow delivery to be interrupted without clogging.
HYPERBRANCH MEDICAL TECHNOLOGY, INC.
NUS-106
In Commercial Distribution
- 00897146002018 ()
- 30897146002019 ()
- Dura mater sealant
GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device
BAXTER HEALTHCARE CORPORATION
1501341
Not in Commercial Distribution
- 50085412086304 ()
- 00085412086309 ()
1501341
- Collagen haemostatic agent, non-antimicrobial
The Tube consists of BioFilmChip Microarray made of a polyester film coated with proprietary multi-layer components designed for DNA analysis as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-5560-01
In Commercial Distribution
- 10850009370232 ()
03-5560-01
- Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only.
REVISION OPTICS, INC.
RD1-1
In Commercial Distribution
- 10850394006013 ()
- 20850394006010 ()
- Diameter
RD1-1
- Corneal inlay, aperture reducing
The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer.
Inspire Medical Systems, Inc.
900-004-031
In Commercial Distribution
- 00855728005109 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system