SerosaFuse® Implantable Fastener Kit

Basic Information

• Brand Name: SerosaFuse® Implantable Fastener Kit
• Primary DI: 00810275014011
• Version / Model: R2275
• Catalog Number: R2275
• Company Name: ENDOGASTRIC SOLUTIONS, INC.
• Labeler DUNS: 143602659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-14
• Public Version: 1
• Public Version Date: 2019-03-22
• Public Version Status: New
• Public Device Record Key: f4dcdac8-518e-49de-9755-cffba5c87e1a

Device Description

Single kit consists of 1 each R2007 EsophyX Z+ Fastener Delivery Device and 1 each R2375 SerosaFuse Implantable Fastener Cartridge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODE	Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37390	Endoscopic suturing unit, single-use	A sterile, manually-operated device intended to be used in combination with a compatible flexible endoscope (e.g., gastroscope, laparoscope) to mechanically approximate the edges of an internal wound or incision with sutures, typically during a gastrointestinal (GI) procedure. It is typically loaded with a needle/suture assembly and attached to the working end, or inserted through the working channel, of the endoscope. The device will also knot and cut the sutures as they are stitched; some types may also carry and/or knot a ligature. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810275014011	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]