Self-Seal Sterilization Pouch
510(k) K141412
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141412 | Date3 Dec 2014 | 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- Withdrawn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
- Full name
- Sterilucent Self-Seal Sterilization Pouch
- 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 Self-Seal Sterilization Pouch is a sterile barrier system designed for packaging medical instruments and devices. It provides a self-contained method of maintaining sterility through sterilization processes such as steam, ethylene oxide, or gamma irradiation. Constructed as a pouch, it ensures protection against contamination during storage and transport. Its design facilitates easy sealing and opening while preserving the sterile integrity of its contents.
This pouch is intended for single-use and is supplied in a non-sterile state prior to sterilization. It is manufactured by GS Medical Packaging, Inc., and has received FDA 510(k) clearance under the traditional review pathway. The pouch is available in a standard size of 3.5 inches by 9 inches (Manufacturer Part # 222101). It is compatible with standard sterilization methods and is intended for use in hospital settings, as indicated by its advisory committee classification. No MRI safety information is provided.
Other devices from Gs Medical Packaging, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the STERILUCENT Self-Seal Sterilization Pouch used for?
The STERILUCENT Self-Seal Sterilization Pouch is designed as a sterile barrier system for packaging medical instruments and devices. Its primary purpose is to protect contents from contamination during sterilization (using steam, ethylene oxide, or gamma irradiation) and subsequent storage or transport. The pouch ensures sterile integrity while allowing easy sealing and opening, making it ideal for hospital environments where maintaining sterility is critical.
Is the STERILUCENT Self-Seal Sterilization Pouch sterile before use?
No, the pouch is supplied in a non-sterile state prior to sterilization. It must undergo sterilization (via steam, ethylene oxide, or gamma irradiation) before use to achieve sterility. This aligns with its single-use design, ensuring contents remain sterile only after proper sterilization.
What sterilization methods are compatible with this pouch?
The STERILUCENT Self-Seal Sterilization Pouch is compatible with standard sterilization methods, including steam sterilization, ethylene oxide gas sterilization, and gamma irradiation. Its design accommodates these processes while preserving the sterility of packaged instruments or devices.
What size is the standard pouch, and are other sizes available?
The standard size for the STERILUCENT Self-Seal Sterilization Pouch is 3.5 inches by 9 inches (Manufacturer Part # 222101). As of the provided data, no alternative sizes are mentioned, so this is the primary offering from GS Medical Packaging, Inc. For larger or smaller needs, contacting the manufacturer directly would be advisable.
How should the STERILUCENT Self-Seal Sterilization Pouch be stored?
While the data does not specify storage conditions explicitly, standard practice for sterile pouches like this one typically involves storing them in a clean, dry environment away from direct sunlight or extreme temperatures. After sterilization, the pouch should be sealed properly to maintain sterility until use. Always follow manufacturer guidelines or facility protocols for optimal storage.