Frequently Asked Questions
Does the device require a prescription to purchase?
Yes, the DermaClip® device is an "Rx Only" device. To complete your first order, a Rx Authorization Form must be submitted to DermaClip® US, LLC. The Authorization form can found here: Rx Authorization.
If interested in an over-the-counter version of DermaClip available to anyone, please visit the DermaQuik Website to purchase emergency wound closure devices for first aid kits. The DermaQuik device is a one-handed closure device that can be used by anyone, anytime, and anywhere skin needs to be closed.
Does the device contain latex?
DermaClip® devices do not contain natural rubber latex.
Should I use adhesive enhancers with DermaClip®?
DermaClip® only uses top-of-the-line, long-duration, pressure sensitive, alkylate-based adhesives. Data sheets on the products are on file with the Company. There is no need to use adhesive enhancers.
Can I get a sample?
If you are interested in obtaining a sample of the DermaClip® device, please email us or fill out the form on the Contact US page with all of your relevant information, including NPI number, and a member of the team will reach out to you to discuss your request.
Do you ship internationally?
No, DermaClip® US, LLC only ships to the United States. For more information on international availability of DermaClip®, please contact the DermaClip® International team at info@DermaClip.com.
How is DermaClip® classified?
DermaClip® is classified as a “Tape and Bandage, Adhesive” in product code KGX by the FDA. The KGX product code is Class 1, 510(k) exempt. DermaClip® has confirmed its classification with the FDA and is a registered device.
Are the manufacturing facilities FDA registered?
The manufacturing facilities are registered with the FDA and comply with the Good Manufacturing Practices ("GMP") described by the US FDA's Quality Systems Regulation ("QSR"), as required by the product's classification.
How is DermaClip® manufactured?
There are 3 main components of DermaClip®, all of which are manufactured and purchased in the US. The device utilizes two medical grade adhesives that are registered with the FDA. Additionally, a food grade plastic is used in production which is sourced from a US-based petrochemical facility. The device is assembled in Mexico.
What certifications do the manufacturing facilities have?
The manufacturing facilities are FDA registered and are subject to US FDA's QSR. In addition, the manufacturing operations have been certified as complying with international standards for the manufacturing of medical devices, having earned ISO 13485 certification.
What sterilization method is used?
DermaClip® utilizes ETO sterilization.