SureLock™

GUDID 00853730006282

Implanted Marker in Needle

CORTEX MANUFACTURING INC.

Brachytherapy 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