ORISE™ Gel M00519230

GUDID 08714729993865

Submucosal lifting agent with needle.

BOSTON SCIENTIFIC CORPORATION

Submucosal lift solution/gel

• Primary Device ID: 08714729993865
• NIH Device Record Key: 09d1d09c-c5e8-43ac-81ab-550f8c3980eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORISE™ Gel
• Version Model Number: M00519230
• Catalog Number: M00519230
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729993858 [Primary]
GS1	08714729993865 [Package]; Contains: 08714729993858; 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