SELF SEAL POUCH - India CDSCO Medical Device Registration

SELF SEAL POUCH is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000303_1e1aa249a3a03358c6a0d22fa5225ee8_098c59953aee769091c7006e122c6412. This device is marketed under the brand name Tyvek Self seal pouch. 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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CDSCO Registered

Class Class B

SELF SEAL POUCH

UID: IMP/MD/2023/000303_1e1aa249a3a03358c6a0d22fa5225ee8_098c59953aee769091c7006e122c6412

Brand Name

Tyvek Self seal pouch

License Holder

Advanced Sterilization Products India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Tyvek® Pouches 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 pouch is intended to maintain sterility of the enclosed device until used.