SterileRight Sterilization Pouch and Roll
by SterileRight Packaging Mfg.Inc. Taiwan EUDAMED510(k)
510(k) K212338 Product code FRG
Overview
The SterileRight Sterilization Pouch and Roll is a sterile barrier system designed to protect medical devices and instruments during sterilization and storage. It is classified as a sterilization pouch and roll, ensuring contamination control for surgical and procedural items.
This product is supplied in sterile form and is intended for single-use, adhering to FDA 510K and MDR regulatory standards. It is available in various sizes and configurations to accommodate different medical devices, ensuring proper sterilization and maintaining sterility until use. The device is manufactured by SterileRight Packaging Mfg., Inc., and is intended for use in hospital settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK212338 | Date1 Nov 2021 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- FRG
- FDA applicant
- Sterileright Packaging Mfg., Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from SterileRight Packaging Mfg.Inc.
Questions
What types of medical devices or instruments can the SterileRight sterilization pouch and roll protect during sterilization and storage?
The SterileRight sterilization pouch and roll is designed to protect a wide range of surgical and procedural items, including medical devices and instruments. Its various sizes and configurations allow it to accommodate different shapes and sizes of equipment, ensuring proper sterilization and maintaining sterility until the time of use in hospital settings.
Is the SterileRight sterilization pouch and roll intended for reuse, or is it meant to be used only once?
The SterileRight sterilization pouch and roll is explicitly intended for single-use only. This design ensures contamination control and maintains sterility standards, aligning with FDA 510K and MDR regulatory requirements.
How is the SterileRight sterilization pouch and roll supplied, and what does that mean for its use?
The SterileRight sterilization pouch and roll is supplied in a sterile form directly from the manufacturer. This means it is pre-sterilized and ready for immediate use with medical devices or instruments, eliminating the need for additional sterilization before packaging.
What regulatory pathways does the SterileRight sterilization pouch and roll follow, and how does that affect its use?
The SterileRight sterilization pouch and roll follows FDA 510K and MDR (Medical Device Regulation) pathways, confirming its compliance with stringent sterilization and contamination control standards. This ensures it meets the necessary regulatory requirements for use in hospital settings as a sterile barrier system.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K212338
- EUDAMED