CHECKPOINT STIMULATOR MANUFACTURED BY NDI MEDICAL, INC.

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CHECKPOINT STIMULATOR

Request for Information Form	Contact Information
Company Name	NDI MEDICAL, INC.
Address	17 ALPHA PARK
City, State, Zip	HIGHLAND HEIGHTS, OH 44143
Country	US
FDA Owner/Operator Phone	216-378-9106
FDA Medical Specialty Code	EN - Ear, Nose, Throat
FDA Product Code	ETN
FDA Classification Name	STIMULATOR, NERVE
FDA Device Classification Code	Standards
FDA Regulation Number	874.1820
FDA Common Generic Name	SURGICAL NERVE STIMULATOR-LOCATOR
FDA Proprietary Device Name	CHECKPOINT STIMULATOR
FDA Owner / Operator Number	9056718
FDA Owner / Operator Name	NDI MEDICAL, LLC
FDA Establishment Registration Number	3006266300
FDA Registered Establishment Name	NDI MEDICAL, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-07-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of NDI MEDICAL, INC.

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	VARIOUS	VARIOUS
2	BLUE TORCH MEDICAL TECHNOLOGIES 200 HOMER AVE ASHLAND TECH. CENTER ASHLAND, MA 01721 US / 508-231-1080	CAVERMAP SURGICAL AID	NERVE STIMULATOR
3	BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. WESTBOROUGH, MA 01581 US 508-898-9300 / 508-898-9300	MONTGOMERY NERVE STIMULATOR (NS1000)	FACIAL NERVE STIMULATOR
4	BOVIE MEDICAL 7100 30TH AVE. NORTH ST. PETERSBURG, FL 33710 US 727-384-2323 / 727-384-2323 113	NEURO-PULSE	NERVE LOCATOR/STIMULATOR
5	GRASS TECHNOLOGIES, AN ASTRO-MED, INC. PRODUCT GRO 53 AIRPORT PARK DRIVE ROCKLAND, MA 02370 US 401-828-4002 / 401-828-4000 244	GRASS MODELS SIU5,SIU8T,SIU7,PSIU6 ISOLATION UNITS; CCU1	GENERAL PURPOSE STIMULUS ISOLATOR
6	GYRUS ENT L.L.C., SUB. OF GYRUS ACMI, INC. 2925 APPLING RD. BARTLETT, TN 38133 US 011-44-189219750 / 508-804-2739	MULTIPLE	VARIOUS
7	HDC CORP. 628 GIBRALTAR CT. MILPITAS, CA 95035 US 408-942-7340 108 / 408-942-7340 108	NEURO-TRACE II	NERVE LOCATION DEVICE
8	LIFE-TECH, INC. 4235 GREENBRIAR DR. STAFFORD, TX 77477 US 281-491-6600 / 281-491-6600	MODEL 6000 FACIAL NERVE STIMULATOR	FACIAL NERVE STIMULATOR
9	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US 763-514-4000 / 901-344-1538	MULTIPLE	MONOPOLAR STIMULATING INSTRUMENTATION
10	MEDTRONIC SOFAMOR DANEK USA, INC. 4340 SWINNEA RD. MEMPHIS, TN 38118 US 763-514-4000 / 901-396-3133 4668	MULTIPLE	MONOPOLAR STIMULATING INSTRUMENTATION
11	MEDTRONIC XOMED, INC. 6743 SOUTHPOINT DR. NORTH JACKSONVILLE, FL 32216 US 763-514-4000 / 904-279-7532	MULTIPLE	VARIOUS
12	NEUROVISION MEDICAL PRODUCTS, INC. 275 BURNETT AVE. VENTURA, CA 93003 US 805-212-8306 / 866-815-6013	LARYNGEAL SURFACE ELECTRODE,LSE500M SERIES	LARYNGEAL SURFACE ELECTRODE
13	NUVASIVE, INC. 4670 E. SHELBY DR. MEMPHIS, TN 38118 US 858-229-9924 / 858-909-1868	INS-1 AND NEUROVISION JJB SYSTEMS	EMG MONITOR/STIMULATOR
14	NUVASIVE, INC. 4545 TOWNE CENTRE COURT SAN DIEGO, CA 92121 US 858-229-9924 / 858-909-1868	NS-1 SYSTEM AND NEUROVISION JJB SYSTEM	ELECTROMYOGRAPHY, EMG MONITOR/STIMULATOR AND ACCESSORY ELECTRODES
15	PARAGON MEDSYSTEMS, LLC. 15920 BERNARDO CENTER DR. SAN DIEGO, CA 92127 US 858-613-1200 36 / 858-613-1200 36	INS-1	EMG MONITOR/STIMULATOR
16	R & D BATTERIES, INC. 3300 CORPORATE CENTER DR. BURNSVILLE, MN 55306 US 952-890-0629 / 952-890-0629 343	MULTIPLE	BATTERY, RECHARGEABLE
17	SINGER MEDICAL PRODUCTS INC., MD SYSTEMS DIV. 3800 BUCKNER EL PASO, TX 79925 US 630-860-6500 / 630-860-6500	AXOSTIM NERVE STIMULATOR	DISPOSABLE NERVE STIMULATOR
18	TELEFLEX MEDICAL 2917 WECK DR. RESEARCH TRIANGLE PARK, NC 27709 US 919-544-8000 / 919-433-4829	MULTIPLE NERVE STIMULATORS	VARIOUS TYPES OF NERVE STIMULATORS
19	THE MAGSTIM COMPANY LTD. SPRING GARDENS, WHITLAND DYFED, WALES, SA34 0HR UK 44-19-94 240798 / 44-19-94 240798	NEUROSIGN MODEL 100-400-800	MOTOR NERVE MONITOR
20	VIASYS NEUROCARE 5225 VERONA RD. MADISON, WI 53711 US 610-862-0800 / 608-441-2065	NO PROPRIETARY NAME LISTED	NERVE STIMULATOR
21	WR MEDICAL ELECTRONICS CO. 123 NO.2ND.STREET STILLWATER, MN 55082 US 651-430-1200 / 651-430-1200	BRACKMANN; HILGER; SILVERSTEIN	FACIAL NERVE STIMULATORS AND MONITORS

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