Tyvek Rolls
- UID
- IMP/MD/2023/000486_63f4556b47c4eb0a6505228ae36e712d_f5009c5bf84ecc9b472fd205a327d868
- Device class
- Class B
- Brand name
- Tyvek Rolls
- License holder
- Advanced Sterilization Products India Private Limited
- Approving authority
- CDSCO
- Product information
- Tyvek® Rolls with STERRAD™ Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the roll is intended to maintain sterility of the enclosed device until used.
Tyvek Rolls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000486_63f4556b47c4eb0a6505228ae36e712d_f5009c5bf84ecc9b472fd205a327d868. This device is marketed under the brand name Tyvek Rolls. The license holder is Advanced Sterilization Products India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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