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Address: 99 Hartwell Street, West Boylston, Maryland 01583, USA
www.luxtec.com |
Send Inquiry |
Phone: +1-(508)-835-9700
Year Established: 1981
Annual Revenues: USD 10-25 Million
Employee Count: ~140
Quality: ISO 9001, CE Certified
Products: Light Sources, Surgical Headlights, Recording Systems, Headlight Box / Light source, Digital Video Recorders, Recording Devices, ...
Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monito
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Address: 50 Harbour Drive South, Boynton Beach, Florida 33435, USA
Phone: +1-(561)-9687111
Products: No Adhesive External Aesthetic Restoration Material (FDA Code:
NOK), ...
Reforma, Llc deals with non adhesive external aesthetic restoration materials.
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Address: West 223 North 720 Saratoga Drive, Suite 120, Waukesha, Wisconsin 53186, USA
www.shoney.com |
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Phone: +1-(262)-970-0170
FDA Registration: 2183650 Year Established: 1986
Annual Revenues: < USD 1 Million
Products: Adhesive Bandages (FDA Code:
KGX), Child Ear Curette, Angular Ear Curette, Buck Ear Curettes, Connecting Flexible Aspirating Tube (FDA Code:
BYY), Cast Bandage (FDA Code:
ITG), ...
Shoney Scientific, Inc. is an OEM medical device manufacturing company. We offer a complete range of custom production services, from prototype development to manufacturing, packaging and sterilizatio
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Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com |
Send Inquiry |
Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code:
HTJ), Depth Gauge (FDA Code:
HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code:
HTJ), ENT Forceps (FDA Code:
KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic
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Address: 4 Carl-Zeiss-Str., Ettlingen D-76275, Germany
www.detax.de |
Send Inquiry |
Phone: +49-(724)-3510-0
FDA Registration: 9680954
Products: Dental Implants, Therapeutic Putty Kits, Calcium Phosphate Cement, Air Conduction Hearing Aid (FDA Code:
ESD), No Adhesive External Aesthetic Restoration Material (FDA Code:
NOK), ...
Detax Gmbh & Co. Kg deals with dental implants. Our products are Implantlink® semi, Pixelbite, Trayloc®A and Blue Eco Scan®. We provide Implantlink® semi, which is a long-term provisio
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EMAIL INQUIRY to 5 No Adhesive External Aesthetic Restoration Material suppliers
FDA Code / Regulation: NOK / 878.3800 An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.