Search Results
Found 1 results
510(k) Data Aggregation
K Number
K101580Device Name
NEV'S INK AUTOCLAVE TAPES
Manufacturer
Date Cleared
2010-07-01
(24 days)
Product Code
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
NEV'S INK, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nev's Ink Autoclave Tapes are used to hold sterilization packs together and as a process indicator in steam sterilizers. When exposed to gravity steam sterilizers operating at 121℃ for 10 minutes and pre-vacuum steam sterilizers operating at 134℃ for 2 minutes, the word "Autoclaved" turns pink. This provides identification of processed items.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1