ASP 110637

GUDID 03760262490465

The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear. It consists of a needle encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP Original exactly on the selected point, and a plunger generating the impulse required for implantation. A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle. The ASP Gold steel needle, with a film of pure Gold, is for use with patients who are allergic.

SEDATELEC

Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use Acupuncture needle, single-use

• Primary Device ID: 03760262490465
• NIH Device Record Key: 6bcfb932-42c5-4adc-9730-bdccf1b36e18
• Commercial Distribution Discontinuation: 2016-09-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ASP
• Version Model Number: ASPG8
• Catalog Number: 110637
• Company DUNS: 266031462
• Company Name: SEDATELEC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com
• Phone: +33472663322
• Email: contact@sedatelec.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760262490465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060392

FDA Product Code

• MQX: Needle, Acupuncture, Single Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-20
• Device Publish Date: 2016-09-22

On-Brand Devices [ASP]

• 03760262490564: The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to b
• 03760262490465: The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to b
• 03760262490427: The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to b