ORISE™ Gel M00519220

GUDID 08714729993841

Submucosal Lifting Agent

BOSTON SCIENTIFIC CORPORATION

Submucosal lift solution/gel

• Primary Device ID: 08714729993841
• NIH Device Record Key: 6f00534a-cd47-4bea-9f55-17d7f449ad38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORISE™ Gel
• Version Model Number: M00519220
• Catalog Number: M00519220
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729993834 [Primary]
GS1	08714729993841 [Package]; Contains: 08714729993834; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• PLL: Submucosal injection agent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-07-29

On-Brand Devices [ORISE™ Gel]

• 08714729993865: Submucosal lifting agent with needle.
• 08714729993841: Submucosal Lifting Agent
• 08714729974598: Submucosal lifting agent with needle.
• 08714729974574: Submucosal Lifting Agent