SureLock™

GUDID 00887868270482

SureLock™ All-Suture Anchor, 1.4mm pre-loaded implant, Flexible Inserter

CAYENNE MEDICAL, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00887868270482
• NIH Device Record Key: 63137987-c19c-4b96-a83b-2e9bd182fa10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureLock™
• Version Model Number: CM-9614F
• Company DUNS: 606719685
• Company Name: CAYENNE MEDICAL, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868270482 [Primary]
HIBCC	M543CM9614F1 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132867

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-29
• Device Publish Date: 2020-09-21

On-Brand Devices [SureLock™]

• 00887868270529: SureLock™ All-Suture Anchor, 2.2mm pre-loaded implant, Flexible Inserter
• 00887868270482: SureLock™ All-Suture Anchor, 1.4mm pre-loaded implant, Flexible Inserter