EsophyX2 HD

GUDID 00810275011065

EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories

ENDOGASTRIC SOLUTIONS, INC.

Endoscopic suturing unit, single-use Endoscopic suturing unit, single-use

• Primary Device ID: 00810275011065
• NIH Device Record Key: 1464a5cf-54a3-4304-9c42-be55477b61ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsophyX2 HD
• Version Model Number: R2005
• Company DUNS: 143602659
• Company Name: ENDOGASTRIC SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810275011065 [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.

• 00810275014011 - SerosaFuse® Implantable Fastener Kit: 2019-03-22 Single kit consists of 1 each R2007 EsophyX Z+ Fastener Delivery Device and 1 each R2375 SerosaFuse Implantable Fastener Cartrid
• 00810275013052 - SerosaFuse® 7.5mm Implantable Fastener Cartridges: 2019-03-21 2 Cartridges, 40 Implantable Fasteners, 7.5mm Web Length
• 00810275011065 - EsophyX2 HD: 2018-07-06EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories
• 00810275011065 - EsophyX2 HD: 2018-07-06 EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories
• 00810275011072 - EsophyX Z: 2018-07-06 EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners and Accessories
• 00810275013014 - 6.5mm Cartridge: 2018-07-06 Cartridge, 20 Fasteners, 0.010" Slot, 6.5mm Web
• 00810275013021 - 7.5mm Cartridge: 2018-07-06 Cartridge, 20 Fasteners, 0.010" Slot, 7.5mm Web
• 00810275013038 - 6.5mm & 7.5mm Cartridge: 2018-07-06 Cartridge, 40 Implantable Fasteners, 6.5mm & 7.5mm Web Length
• 00810275011089 - EsophyX Z+: 2018-03-29 EsophyX Z+ Fastener Delivery Device with SerosaFuse Fasteners and Accessories