Insulated Clik-Tite 8001-064-035

GUDID 07613327175301

STRYKER CORPORATION

External cuff/pad connection tubing

• Primary Device ID: 07613327175301
• NIH Device Record Key: 71eb94e1-412d-44d5-b54b-9e895ea9571d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insulated Clik-Tite
• Version Model Number: 8001-064-035
• Catalog Number: 8001-064-035
• Company DUNS: 078470558
• Company Name: STRYKER CORPORATION
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327175301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152266

FDA Product Code

• DWJ: System, thermal regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-12-16

Devices Manufactured by STRYKER CORPORATION

• 07613327634914 - Neptune: 2024-04-24 SMART DOCKING STATION (120V)
• 07613327627664 - KNOTILUS+: 2024-03-15 2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK
• 07613327627701 - KNOTILUS+: 2024-03-15 2.4X8.9MM KNOTILUS+ HIP ANCHOR - PEEK
• 07613327623796 - KNOTILUS+: 2024-03-13 2.4X8.9MM DRILL, HIP
• 07613327623833 - KNOTILUS+: 2024-03-13 2.4X8.9MM DRILL, HARD BONE, HIP
• 07613327634686 - Iconix: 2024-03-12 Iconix DC Guide for 1.4mm anchor
• 07613327634693 - Iconix: 2024-03-12
• 07613327616675 - SPY: 2024-03-06