Disposable Endoscopic Linear Cutter Staplers and Reloads

GUDID 06946480589311

Sinolinks Medical Innovation Co., Ltd.

Endoscopic manual linear cutting stapler, single-use

• Primary Device ID: 06946480589311
• NIH Device Record Key: d56f96ff-a192-4ded-9b7d-535a150ff4eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Endoscopic Linear Cutter Staplers and Reloads
• Version Model Number: DEC-B 60
• Company DUNS: 528192598
• Company Name: Sinolinks Medical Innovation Co., Ltd.
• 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: true
• Manufacturing Date: true
• 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	06946480589311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131511

FDA Product Code

• GDW: Staple, Implantable

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: 2025-09-12
• Device Publish Date: 2025-09-04

On-Brand Devices [Disposable Endoscopic Linear Cutter Staplers and Reloads ]

• 06946480589373: DER B 60P
• 06946480589366: DER B 60T
• 06946480589311: DEC-B 60