Max. value paid with public resources: Processing

Data for med. device

Medical device code

01AIMDN3600789719

Form date

19/09/2021 12:20

Record date MD

20/09/2021 10:05

Date introduce requestor in the system

10/06/2021 09:37

Identification of the manufacturer

Manufacturer name, long

Boston Scientific Neuromodulation Corporation

Name of the manufacturer, short

BSCI

Code type

EIK

Code

411344804

Country code

US

City

Valencia

Postal code

CA 91335

Street, number

25155 Rye Canyon Loop

Contact person

Adele Shoustal

Phone

+1 6619494046

E-mail

adele.shoustal@bsci.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

Nestmar Medical LTD

Code type

EIK

Code

206260081

Country code

BG

Region code

SOF

City

Sofia

Postal code

1415

Street, number

Okolovrasten put 42

Contact person

Slavi Nestorov

Phone

+359878112319

E-mail

office@nestmarmedical.com

Identification of the wholesaler

Wholesaler name

Nestmar Medical LTD

Code type

EIK

Code

206260081

Country code

BG

Region code

SOF

City

Sofia

Postal code

1415

Street, number

Okolovrasten put 42

Contact person

Slavi Nestorov

Phone

+359878112319

E-mail

office@nestmarmedical.com

Number of authorization/certificate for wholesale trade with medical devices

BG/WDA/MD-0328

Date of authorization/certificate for wholesale trade with medical devices

30/11/2020

General medical information about the device

Category of the medical device

01 - Active implantable medical devices

Risk clasification

Active implantable medical devices

Anatomical group

Nervous system

Code type

GMDN

Code value

36007

Name	Artisan 50 cm 2x8 Surgical Lead Kit

Model

SC-8216-50

Description of the medical device

Number in one package

1

Characteristics

Sterility, Hospital prescription

Intended action by the manufacturer

Purpose

Leads function as a component of Boston Scientific’s Spinal Cord Stimulation (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain sensation.

Usage

Single use

Number in catalog

M365SC821650

General trade information

Max. value paid with public resources

Processing

BDA registration number

BG/WDA/MD-0328

BDA registration date

30/11/2020

CE certificate number

I7 065561 0036 Rev. 01

CE certificate expiration date

26/05/2024