CQ'ENCE Circular Stapler 34mm CS34

GUDID B092CS340

SECQURE SURGICAL, CORP.

Surgical staple loading unit, non-cutting Surgical staple loading unit, non-cutting

• Primary Device ID: B092CS340
• NIH Device Record Key: 3d26717c-08b9-4828-9a6d-dc0a9ff62fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CQ'ENCE Circular Stapler 34mm
• Version Model Number: CS34
• Catalog Number: CS34
• 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	B092CS340 [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