Insulated Clik Tite 8001-064-037

GUDID 07613327175295

STRYKER CORPORATION

External cuff/pad connection tubing

• Primary Device ID: 07613327175295
• NIH Device Record Key: 4268a1f5-a9ed-4aa3-b5e6-dcb7044df1b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insulated Clik Tite
• Version Model Number: 8001-064-037
• Catalog Number: 8001-064-037
• 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	07613327175295 [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

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