SureLock™

GUDID 00853730006282

Implanted Marker in Needle

CORTEX MANUFACTURING INC.

Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle

• Primary Device ID: 00853730006282
• NIH Device Record Key: 6b6a228f-29a8-496a-9e08-dcb061c4d00e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureLock™
• Version Model Number: FM-1.2-1-0-GG-17-20
• Company DUNS: 832596816
• Company Name: CORTEX MANUFACTURING INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853730006282 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100267

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2018-07-06
• Device Publish Date: 2015-08-24

Devices Manufactured by CORTEX MANUFACTURING INC.

• 00853730006008 - FlexiMarc™: 2018-07-06 Implanted Marker in Needle
• 00853730006015 - FlexiMarc™: 2018-07-06 Implanted Marker in Needle
• 00853730006022 - FlexiMarc™: 2018-07-06 Implanted Marker in Needle
• 00853730006039 - FlexiMarc™: 2018-07-06 Implanted Marker in Needle
• 00853730006046 - FlexiCoil™: 2018-07-06 Implanted Marker in Needle
• 00853730006053 - FlexiCoil™: 2018-07-06 Implanted Marker in Needle
• 00853730006060 - FlexiCoil™: 2018-07-06 Implanted Marker in Needle
• 00853730006077 - FlexiCoil™: 2018-07-06 Implanted Marker in Needle