Sure-Check™

GUDID 10889950134099

Pouches Pack

HU-FRIEDY MFG. CO., LLC

Sterilization packaging, single-use

• Primary Device ID: 10889950134099
• NIH Device Record Key: 8fb83a9a-20d0-4560-98f9-b089b3431126
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-Check™
• Version Model Number: SP-POUCH
• Company DUNS: 005085972
• Company Name: HU-FRIEDY MFG. CO., LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com
• Phone: +1(800)483-7433
• Email: info@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889950134099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941327

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-21
• Device Publish Date: 2022-03-11

Devices Manufactured by HU-FRIEDY MFG. CO., LLC

• 10889950145446 - Hu-Friedy: 2025-01-31 MTO OS SIG CASS,BLK,C6,E4,5REG,15LP,AW4
• 10889950145453 - Hu-Friedy: 2025-01-31 MTO OS SIG CASS,GRN,C6,E4,5REG,15LP,AW4
• 10889950145019 - Hu-Friedy: 2025-01-13 Mini Urban Sinus Lift Instrument #4
• 10889950145378 - Hu-Friedy: 2024-11-28 MTO INFINITY 3 INST EXAM CASS,WHITE,ACC
• 10889950145385 - Hu-Friedy: 2024-11-28 MTO INFINITY SM UI/2INST RAILS,WHITE,ECR
• 10889950145330 - Hu-Friedy: 2024-11-12 MTO INFINITY 16 INST CASS,BLACK,2 CLIPS
• 10889950145347 - Hu-Friedy: 2024-11-12 MTO INFIN 12 INS SIGNAST CASS,GRN,ALL LP
• 10889950145354 - Hu-Friedy: 2024-11-12 MTO INFINITY 12 INST CASS,BLUE,E2,C4,NH