Search Results
Found 1 results
510(k) Data Aggregation
K Number
K233578Device Name
BAHADIR STERILIZATION CONTAINERS
Manufacturer
Date Cleared
2024-03-22
(136 days)
Product Code
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
Bahadir USA LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Bahadir Sterilization Containers are reusable, metal, sterilization containers. They are designed for holding operating room instruments and/or textiles during low temperature hydrogen peroxide sterilization procedures and for maintaining sterlity during storage and transport under proper hospital conditions. This container system is compatible for use with the following low temperature sterilizers and the cycles identified below:
*STERIS V-PRO maX/maX2 - Lumen, Non-Lumen and Flexible Cycles *STERIS V-PRO s2/60 - Lumen, Non-Lumen and Flexible Cycles *STERRAD 100NX - Duo, Express, Standard and Flex Cycles *STERRAD NX - Standard and Advanced Cycles
Device Description
The Bahadir Sterilization Containers are a reusable container system intended for sterilization and storage of other medical devices. This container system is compatible for use with the following low temperature sterilizers and cycles identified below:
- STERIS VPRO maX/maX2: Lumen, Non Lumen, Flexible
- STERIS VPRO s2/60: Lumen, Non Lumen, Flexible ●
- STERRAD NX: Standard, Advanced ●
- . STERRAD 100NX: Standard, Express, Flex, Duo
Ask a Question
Ask a specific question about this device
Page 1 of 1