GRAFTSITE

GUDID 15060238201145

GRAFTSITE Delivery Assistance Device

SUMMIT MEDICAL LIMITED

Anaesthesia conduction catheter

• Primary Device ID: 15060238201145
• NIH Device Record Key: 96c1922c-0c46-4a83-a55d-91173368d5ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAFTSITE
• Version Model Number: D201045
• Company DUNS: 221751311
• Company Name: SUMMIT MEDICAL LIMITED
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441451821311
• Email: info@summit-medical.co.uk
• Phone: +441451821311
• Email: info@summit-medical.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060238201145 [Primary]
GS1	25060238201142 [Package]; Package: Cardboard Carton [5 Units]; In Commercial Distribution
GS1	35060238201149 [Package]; Contains: 25060238201142; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173110

FDA Product Code

• CAZ: Anesthesia Conduction Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-04
• Device Publish Date: 2018-12-21

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