Single Use Circular Stapler

GUDID 16946912215013

Golden Stapler Surgical Co.,Ltd

Intraluminal circular stapler, single-use

• Primary Device ID: 16946912215013
• NIH Device Record Key: 39730ffd-eb2c-40ca-a154-15934c1dcc99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Circular Stapler
• Version Model Number: CSA21
• Company DUNS: 527606074
• Company Name: Golden Stapler Surgical Co.,Ltd
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06946912215016 [Primary]
GS1	16946912215013 [Package]; Contains: 06946912215016; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162707

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: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [Single Use Circular Stapler]

• 16946912216034: CSB26
• 16946912216027: CSB23
• 16946912216010: CSB21
• 16946912215068: CSA34
• 16946912215051: CSA32
• 16946912215044: CSA29
• 16946912215037: CSA26
• 16946912215020: CSA23
• 16946912215013: CSA21
• 16946912217062: CSC34
• 16946912217055: CSC32
• 16946912217048: CSC29
• 16946912217031: CSC26
• 16946912217024: CSC23
• 16946912217017: CSC21
• 16946912216065: CSB34
• 16946912216058: CSB32
• 16946912216041: CSB29