Eagle Pac/Visible Seal

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K781699 ↗

FDA Product Code

KCT

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from American Sterilizer Co. →

• What is the Eagle PAC/VISIBLE SEAL Sterility Maintenance Cover used for?

  The Eagle PAC/VISIBLE SEAL is designed to act as a sterile barrier for hospital and clinical packs or pouches, preventing contamination from dust and moisture during storage and transport. Its transparent material allows users to visually verify the contents and sterility without breaking the seal, which is critical in maintaining a sterile field in healthcare settings.

• Is the Eagle PAC/VISIBLE SEAL sterile when supplied?

  No, the Eagle PAC/VISIBLE SEAL is supplied as a non-sterile item. It is intended to be placed over already sterilized packs or pouches to maintain their sterility during handling, storage, and transport. The cover itself must not be considered sterile until properly sealed over a sterile load.

• How is the Eagle PAC/VISIBLE SEAL sealed, and is it reusable?

  The cover features a fold-over, self-sealing adhesive strip that creates a secure barrier when applied. It is designed for single-use only—once opened or compromised, the cover should be discarded to avoid contamination risks. The adhesive ensures a tight seal without requiring additional tools.

• What sizes are available for the Eagle PAC/VISIBLE SEAL?

  The Eagle PAC/VISIBLE SEAL is available in specific dimensions, including 10 x 15 inches, as documented by the manufacturer. These sizes are standardized to accommodate common hospital pack configurations. For exact sizing needs, refer to the manufacturer’s product specifications or packaging.

• How should the Eagle PAC/VISIBLE SEAL be stored before use?

  Before use, store the cover in a clean, dry environment following standard sterile barrier protocols to prevent contamination. Avoid exposure to direct sunlight, moisture, or extreme temperatures, as these can degrade the adhesive or material integrity. The cover should remain unopened until ready to seal a sterile pack.