CryoLife, Inc.

Lot Code 17MJX002, Model/Catalog Number BG3510-5-J

Cardiovascular Devices

3

Yes

Product distributed in Japan.

BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

Serial #'s: 4622210, 4587605, 4741470, 4750714, 4622025, 4737722, 4737726, 4632012, 4237725, 4616112, 4520208, 4520709, 4632013, 4771217, 4771005, 4781414, 4782107, 4782132, 4765118, 4750707, 4508717, 4525417, 4520719, 4771302, 4771302, 4771210, 4751315, 4741406, 4616313, 4781416, 4771305, 4737922, 4520711, 4508804, 4508807, 4712108, 4765119, 4765106, 4587712, 4525415, 4622315, 4622126, 4771205, 4001123, 4771202, 4780914, 4741412, 4717904, 4671765, 458719, 4622225, and 4731908

Cardiovascular Devices

3

Yes

Worldwide Distribution - US Nationwide in the states of AL, CA, FL, IA, IN, LA, MA, MN, MO, MS, NC, OR, PA, and TN. and the countries of Finland, United Kingdom and Israel

On-X Prosthetic Heart Valve || Product Usage: || Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902

Cardiovascular Devices

3

Yes

US Distribution to the state of : Illinois

On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. || Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

Serial Number 10988203

Cardiovascular Devices

Unclassified

Yes

AR, OH

Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

Serial Number 10988328

Cardiovascular Devices

2

Yes

AR, OH

Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020