Endo-Ease Discovery Low Profile EED-250

GUDID 00867630000219

Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.

SPIRUS MEDICAL LLC

Endoscopic overtube, single-use

• Primary Device ID: 00867630000219
• NIH Device Record Key: 76878075-1972-4960-9053-ed9e7641a4a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Ease Discovery Low Profile
• Version Model Number: EED-250
• Catalog Number: EED-250
• Company DUNS: 969696975
• Company Name: SPIRUS MEDICAL LLC
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 508-584-1596
• Email: ejohnson@primomedicalgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867630000219 [Primary]
GS1	20867630000206 [Package]; Package: box [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080050

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

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: 2016-09-23

Devices Manufactured by SPIRUS MEDICAL LLC

• 00867630000202 - Endo-Ease Vista Retrograde: 2018-07-06 Endo-Ease Endoluminal Advancement System
• 00867630000219 - Endo-Ease Discovery Low Profile: 2018-07-06Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and enteroscopy.
• 00867630000219 - Endo-Ease Discovery Low Profile: 2018-07-06 Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and e
• 00867630000226 - Endo-Ease Discovery Standard Profile: 2018-07-06 Overtube to aid endoscopic insertion and advancement to the mid-ileum during diagnostic and therapeutic upper GI endoscopy and e
• 00867630000233 - Endo-Ease Lubricant: 2018-07-06 A water soluble and intended for medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic d