Tidi Brand Sterilization Wrap
by Banta Healthcare Group, Ltd.
510(k) K042580
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042580 | Date17 Nov 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tidi Brand Sterilization Wrap is a sterilization wrap (product code: FRG) designed as a protective barrier for medical and dental instruments, equipment, and kits during sterilization processes. It functions as a single-use barrier to prevent contamination during steam sterilization, ensuring sterile packaging for subsequent use. Constructed for use in both medical and dental facilities, it adheres to regulatory standards for sterilization protection.
This wrap is supplied as a single-use disposable product, intended exclusively for steam sterilization applications. It is not reusable and must be discarded after one use to maintain sterility. The product is authorized under FDA 510(k) clearance (K042580) and is classified under the General Hospital advisory committee category. Available in multiple sizes, it requires proper storage to preserve integrity before use, with no specific MRI safety considerations.
Other devices from Banta Healthcare Group, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Tidi Brand Sterilization Wrap used for?
The Tidi Brand Sterilization Wrap acts as a protective barrier during steam sterilization to prevent contamination of medical and dental instruments, equipment, and kits. It ensures sterile packaging for safe, subsequent use in clinical settings. The wrap is specifically designed for single-use applications to maintain sterility integrity.
Is the Tidi Brand Sterilization Wrap reusable?
No, the Tidi Brand Sterilization Wrap is intended for single-use only. Reusing the wrap compromises its sterility and protective barrier function, which could lead to contamination of sterilized items. Discarding it after one use ensures compliance with sterilization protocols.
What sizes are available for the Tidi Brand Sterilization Wrap?
The Tidi Brand Sterilization Wrap is available in multiple sizes to accommodate various medical and dental instruments, equipment, and kits. While exact dimensions are not specified, the product is designed to provide flexibility for different sterilization needs. Check manufacturer documentation for specific size options.
How should the Tidi Brand Sterilization Wrap be stored?
The wrap must be stored in a way that preserves its integrity before use. This includes keeping it in a clean, dry environment away from direct sunlight, moisture, or sharp objects that could compromise its protective barrier. Proper storage ensures the wrap remains effective for its intended single-use application.
Does the Tidi Brand Sterilization Wrap have any MRI safety considerations?
No, the Tidi Brand Sterilization Wrap does not have any specific MRI safety considerations. It is designed solely for use as a protective barrier during steam sterilization and does not contain materials that would interfere with MRI procedures or equipment.