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

• 10889950154578 - Hu-Friedy: 2026-02-10 MTO INFINITY 16INST CASS,PURPLE,FM IN AC
• 10889950145590 - Hu_Friedy: 2026-02-09 #5/6 Barnhart Curette, Satin Steel, DULL
• 10889950154424 - Hu-Friedy: 2026-02-09 Statim,Orng, 8 LP,2 REG,E1,N1,FM in acc
• 10889950154332 - Hu-Friedy: 2026-02-03 SPECIAL SIGNA-STAT, RED, 2C/1NH
• 10889950145569 - Hu_Friedy: 2026-01-30 #204 DE SCALER, DULL
• 10889950145576 - Hu_Friedy: 2026-01-30 NEVI 1 Anterior D/E Satin Steel, DULL
• 10889950145583 - Hu_Friedy: 2026-01-30 #13/14 COLUMBIA DE CURETTE, DULL
• 10889950145606 - Hu_Friedy: 2026-01-30 #11/12 Gracey Curette, Satin Steel, DULL