CQ'ENCE Circular Stapler 28mm CS28

GUDID B092CS280

SECQURE SURGICAL, CORP.

Surgical staple loading unit, non-cutting

• Primary Device ID: B092CS280
• NIH Device Record Key: f39c349a-47d7-459c-b738-c403c5032bb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CQ'ENCE Circular Stapler 28mm
• Version Model Number: CS28
• Catalog Number: CS28
• Company DUNS: 079554198
• Company Name: SECQURE SURGICAL, CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B092CS280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120179

FDA Product Code

• GDW: Staple, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-10-25