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
Primary Device ID17290016814351
NIH Device Record Keyc22f1e4d-e900-4560-a39d-10e9ec8881ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyGel
Version Model NumberEndyGel 350 ml
Catalog NumberND_PRD00016
Company DUNS531958689
Company NameENDYMED MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814354 [Primary]
GS117290016814351 [Package]
Contains: 07290016814354
Package: Carton [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GYBMedia, Electroconductive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-12
Device Publish Date2023-07-04

Devices Manufactured by ENDYMED MEDICAL LTD

07290016814408 - EndyMed PRO MAX, System, 110V2024-05-24 The EndyMed PRO MAX System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-
07290016814415 - endyMed PRO MAX, Intensif MAX Handpiece2024-05-24 The Intensif applicator is intended for use in dermatologic and general surgical procedure for electrocoagulation nd hemostasis
07290016814422 - EndyMed PRO MAX, Small MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814439 - EndyMed PRO MAX, FSR MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814446 - EndyMed PRO MAX, iFine MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814453 - EndyMed PRO MAX,Shaper MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic
07290016814460 - EndyMed PRO MAX,Mini Shaper MAX Handpiece2024-05-24 The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologi
07290016814477 - EndyMed PRO MAX, Contour MAX Handpiece2024-05-24 The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator fo
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