EndyGel ND_PRD00016

GUDID 17290016814351

EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contract between the electrode surface and the skin.

ENDYMED MEDICAL LTD

Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel Skin topical coupling gel

• Primary Device ID: 17290016814351
• NIH Device Record Key: c22f1e4d-e900-4560-a39d-10e9ec8881ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndyGel
• Version Model Number: EndyGel 350 ml
• Catalog Number: ND_PRD00016
• Company DUNS: 531958689
• Company Name: ENDYMED MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com
• Phone: 1-855-363-9633
• Email: support@endymed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016814354 [Primary]
GS1	17290016814351 [Package]; Contains: 07290016814354; Package: Carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161715

FDA Product Code

• GYB: Media, Electroconductive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-12
• Device Publish Date: 2023-07-04

Devices Manufactured by ENDYMED MEDICAL LTD

• 17290014660127 - NEWA+, Kit, US, PINK: 2023-11-28 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin
• 17290016814351 - EndyGel: 2023-07-12EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating current) of the contract between the electrode surface and the skin.
• 17290016814351 - EndyGel: 2023-07-12 EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating curren
• 07290016814361 - PURE Laser, System: 2023-06-27 The PURE Laser system is a non-invasive laser based system used for Hair Removal
• 07290016814378 - PURE Laser, EPL810 HP: 2023-06-27 The handpiece of the PURE Laser system which delivers pulsed laser light (wavelength 810nm) from the diode array to the treatme
• 17290014660110 - NEWA PLUS Kit: 2022-01-17 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin
• 07290014660083 - NEWA Kit: 2021-10-01 The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles
• 17290014660028 - NEWA PLUS Kit: 2021-05-06 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin
• 07290014660014 - NEWA PLUS Kit: 2021-04-28 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin