Sure-Check™

GUDID 10889950134099

Pouches Pack

HU-FRIEDY MFG. CO., LLC

Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use Sterilization packaging, single-use 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

• 10889950143503 - Hu-Friedy: 2024-05-15 MTOINFIN HGD 16INS CASS,OCN,FM ACC,2COMP
• 10889950143480 - Hu-Friedy: 2024-05-10 MTO 20INST SIG,CASS,GREEN,C8,1SNAP-IN AW
• 10889950143497 - Hu-Friedy: 2024-05-10 MTO 10 INSTR SIG CASS,GREEN,1SNAP-IN AW
• 10889950005603 - HU-FRIEDY: 2024-05-09 #4 Felt Anodized Composite Inst.
• 10889950005610 - HU-FRIEDY: 2024-05-09 #5 Felt Anodized Composite Inst.
• 10889950005627 - HU-FRIEDY: 2024-05-09 #6 Felt Anodized Composite Inst.
• 10889950005658 - HU-FRIEDY: 2024-05-09 #3 Goldstein Anodized Composite Inst.
• 10889950005665 - HU-FRIEDY: 2024-05-09 #4 Goldstein Anodized Composite Inst.