6.5mm Cartridge

GUDID 00810275013014

Cartridge, 20 Fasteners, 0.010" Slot, 6.5mm Web

ENDOGASTRIC SOLUTIONS, INC.

Endoscopic suturing unit, single-use

• Primary Device ID: 00810275013014
• NIH Device Record Key: 5145af5f-8c7a-4ae0-9119-d73868bfbefe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6.5mm Cartridge
• Version Model Number: R2165
• Company DUNS: 143602659
• Company Name: ENDOGASTRIC SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Customer Support Contacts

• Phone: 425-307-9269
• Email: customerservice@endogastricsolutions.com
• Phone: 425-307-9269
• Email: customerservice@endogastricsolutions.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810275013014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142113

FDA Product Code

• ODE: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

Devices Manufactured by ENDOGASTRIC SOLUTIONS, INC.

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