Search Results
Found 1 results
510(k) Data Aggregation
K Number
K183263Device Name
UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope
Manufacturer
Date Cleared
2019-06-14
(203 days)
Product Code
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
UNiPACK Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.
Device Description
The UNIPACK Barrier Sleeve and Barrier Film consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, curing lights, air/water syringes, and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, etc. The devices are sold non-sterile, prepackaged, and are for single use only.
Ask a Question
Ask a specific question about this device
Page 1 of 1