Kodak T-Mat C Film SO-119

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K843149 ↗

FDA Product Code

LWZ

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What types of soft tissue applications is the Kodak T-Mat C Film SO-119 intended for in surgical settings?

  The Kodak T-Mat C Film SO-119 is designed as a temporary or permanent biological substitute to provide structural support and aid wound healing in soft tissue applications. Its thin profile (less than 6mm) makes it suitable for procedures requiring precise tissue integration, such as reconstructive or plastic surgery where soft tissue reinforcement is needed.

• Is the Kodak T-Mat C Film SO-119 reusable, or is it meant for single-use only?

  The Kodak T-Mat C Film SO-119 is explicitly supplied as a sterile, single-use product. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and integrity, which are critical for maintaining safety and efficacy in surgical applications.

• How should the Kodak T-Mat C Film SO-119 be stored to ensure it remains usable?

  Since it is a sterile medical device, storage must follow standard sterile medical device protocols. This includes keeping it in a sealed, protective packaging until use and avoiding exposure to moisture, extreme temperatures, or contamination. Always check the packaging for integrity before opening to ensure sterility is preserved.

• What regulatory pathway was followed for FDA clearance of the Kodak T-Mat C Film SO-119?

  The device was cleared through the traditional 510(k) pathway under clearance number K843149, filed in August 1984. It was determined to be substantially equivalent to a predicate device, with no third-party review involved. The classification is Class III, and it falls under product code LWZ for tissue grafts under 6mm.