PERCEVAL S

GUDID 08022057014771

SORIN GROUP ITALIA SRL

Self-expandable heart valve prosthesis post-dilation balloon catheter

• Primary Device ID: 08022057014771
• NIH Device Record Key: 1b9b54e7-91ab-4fa9-8c00-cfb672e17e90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERCEVAL S
• Version Model Number: ICV1216
• Company DUNS: 428011907
• Company Name: SORIN GROUP ITALIA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08022057014771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150011

FDA Product Code

• LWR: heart-valve, non-allograft tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-07-04
• Device Publish Date: 2016-06-06

On-Brand Devices [PERCEVAL S]

• 18022057015034: ICV1268
• 08022057014849: ICV1236
• 08022057014832: ICV1235
• 08022057014887: ICV1245
• 08022057014870: ICV1244
• 08022057014863: ICV1243
• 08022057014856: ICV1242
• 08022057014733: ICV1219
• 08022057014979: ICV1241
• 08022057014825: ICV1234
• 08022057014795: ICV1218
• 08022057014788: ICV1217
• 08022057014771: ICV1216
• 08022057014337: ICV1170
• 08022057014252: ICV1149
• 08022057014245: ICV1148