OverTube Endoscopic Access System OVT-S27-160

GUDID 10811955020695

OverTube (Sterile)

Apollo Endosurgery, Inc.

Endoscopic overtube, single-use

• Primary Device ID: 10811955020695
• NIH Device Record Key: b16f2831-ea85-445e-9644-bb6a5b1eabb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OverTube Endoscopic Access System
• Version Model Number: OVT-S27-160
• Catalog Number: OVT-S27-160
• Company DUNS: 625064352
• Company Name: Apollo Endosurgery, Inc.
• 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: true
• 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: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com
• Phone: 855-551-3123
• Email: productcomplainrs.us@apolloendo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811955020695 [Primary]
GS1	20811955020692 [Package]; Package: Kit [3 Units]; In Commercial Distribution

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: 4
• Public Version Date: 2023-05-15
• Device Publish Date: 2016-08-17

On-Brand Devices [OverTube Endoscopic Access System]

• 10811955020701: OverTube (Non-Sterile)
• 10811955020695: OverTube (Sterile)