Integra™Endoscopic Gastro Release System

Basic Information

• Brand Name: Integra™Endoscopic Gastro Release System
• Primary DI: 10381780280705
• Version / Model: 310040
• Catalog Number: 310040
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-17
• Public Version: 3
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 88ef572a-acbe-472c-8864-96b97eab418a
• Distribution End Date: 2026-12-31

Device Description

INTEGRA™ ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR157)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NBH	Accessories, arthroscopic	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44091	Arthroscopic surgical procedure kit, non-medicated, reusable	A collection of various surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M2483100401	HIBCC
Primary	10381780280705	GS1

Customer Contacts

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