84E Series Single Ply Wrapper
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102864 FDA 510(k)
- FDA Product Code
- FRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 84E Series Single Ply Wrapper is a sterile barrier wrapper (Product Code: FRG) designed to protect medical devices during sterilization and storage. Constructed from liquid-resistant poly/carbon fabric with Merrow Edge stitching, it provides a single-ply barrier to maintain sterility and prevent contamination of enclosed devices.
These wrappers are intended for single-use in healthcare settings, meeting CSA Z314 Level 2 standards for sterilization barriers. Supplied in color-coded sizes with barcode tracking for inventory management, they are authorized under FDA 510(k) clearance (K102864) and must be discarded after use to ensure sterility integrity. No reusable or MRI-compatible variants are specified.
Frequently asked questions
What is the 84E Series Single Ply Wrapper used for in a clinical setting?
The 84E Series Single Ply Wrapper is designed as a sterile barrier wrapper to protect medical devices during sterilization and storage, ensuring they remain uncontaminated. It is specifically engineered to maintain sterility integrity for single-use applications in healthcare environments, preventing exposure to liquids and external contamination.
Are these wrappers reusable, or are they meant for one-time use?
These wrappers are explicitly intended for single-use only in healthcare settings. The manufacturer emphasizes that they must be discarded after use to preserve sterility, as reuse could compromise the integrity of the sterile barrier and expose devices to contamination.
How do I identify the correct size for my medical devices, and does this product include any inventory tracking features?
The 84E Series comes in color-coded sizes to help match the appropriate wrapper to your devices. Additionally, each wrapper includes a barcode for easy inventory management, allowing you to track stock levels efficiently in your facility.
What materials are used in the construction of the 84E Series, and how does this affect its performance?
The wrapper is made from liquid-resistant poly/carbon fabric, which provides a durable yet flexible barrier. The Merrow Edge stitching reinforces the edges, ensuring a secure seal that maintains sterility during sterilization and storage. This construction meets CSA Z314 Level 2 standards, which are critical for protecting devices from contamination.
How should I store these wrappers to ensure they remain effective when needed?
While the data does not specify exact storage conditions, the wrappers are sterile upon packaging and should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since they are single-use, avoid opening or handling them until ready for use to prevent contamination before sterilization.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 84E SERIES SINGLE PLY WRAPPER (K102864) — FDA 510(k) | Innolitics, Wrappers, Level 2, Single Ply, Merrow Edge - Lac-Mac, Limited, 84E SERIES SINGLE PLY WRAPPER 510 (k) K102864 - FDA.report, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Sevice 4 1
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102864 | Class II | Active |
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Manufacturer
- Manufacturer
- Lac Mac, Ltd.
Sources (1)
- FDA 510(k) K102864 24 fields · synced Sep 19, 2026