Additional Information

Frequently Asked Questions

General

Does the device contain latex?
The DermaClip® device only uses non-latex materials. Both the plastic and the adhesive used in the device are non-latex materials.

Is DermaClip® hypo-allergenic?
DermaClip® only uses hypo-allergenic adhesives. The device's inputs are top-of-the-line, long-duration, hypoallergenic, alkylate-based adhesives. Data sheets on the products are on file with the Company. There is no need to use adhesive enhancers.

Does the require a prescription to purchase?
Yes, the DermaClip® device is currently an "Rx Only" device.

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.


Regulatory

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.


Manufacturing

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 China.

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 earning both ISO 13485 certification and the CE Mark.

What sterilization method is used?
DermaClip® utilizes ETO sterilization.