Dermacare Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Dermacare Products, Inc. makes
Dermacare Products, Inc. manufactures surgical and procedural accessories, including reusable and disposable items like tube positioners, dispersive electrodes for infant electrosurgery, and reusable surgical drapes. Their portfolio also covers reusable surgical wipes, skin markers for dermatological procedures, and bipolar electrosurgical cords designed for single-use. Additional products include a reusable device for counting surgical instruments and a reusable surgical cleaning brush.
The company’s devices are regulated under FDA’s Class I and Class II classifications, with most products authorised via the 510(k) pathway. These items are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Surgi-Tek Tube Positioner Ref K863279
Regimes: 510(k) Registry: 510(k)Infant Electrosurgical Dispersive Electrode Ref K882421
Regimes: 510(k) Registry: 510(k)Correct-A-Count Ref K853374
Regimes: 510(k) Registry: 510(k)Pro-Clean Ref K862367
Regimes: 510(k) Registry: 510(k)Elan-E Disposalbe Drape Ref K882494
Regimes: 510(k) Registry: 510(k)Surgi-Wipes Ref K863278
Regimes: 510(k) Registry: 510(k)Dermamarker Ref K863280
Regimes: 510(k) Registry: 510(k)Surgitek Disposable Bipolar Cord Ref K871910
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dermacare Products, Inc. have in the registry?
The registry currently lists 8 devices for Dermacare Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dermacare Products, Inc.'s devices?
Among its 8 most recently registered devices, Dermacare Products, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Dermacare Products, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Dermacare Products, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dermacare Products, Inc. in the registry?
The most recently registered devices listed for Dermacare Products, Inc. include SURGI-TEK TUBE POSITIONER, INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE, CORRECT-A-COUNT and PRO-CLEAN.