ORISE™ ProKnife

GUDID 08714729995593

ORISE 2.0 mm Electrode - Kitted Device

BOSTON SCIENTIFIC CORPORATION

Endoscopic electrosurgical submucosal lift/resection instrument

• Primary Device ID: 08714729995593
• NIH Device Record Key: 9715b6f8-2195-4d84-90dd-6f871eb126c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORISE™ ProKnife
• Version Model Number: M00519390
• 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	08714729995593 [Primary]

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [ORISE™ ProKnife]

• 08714729995579: Electrosurgical knife
• 08714729995562: Electrosurgical knife
• 08714729995555: Electrosurgical knife
• 08714729999904: ORISE PROKNIFE 3.0 mm Electrode
• 08714729999898: ORISE PROKNIFE 2.0 mm Electrode
• 08714729999881: ORISE PROKNIFE 1.5 mm Electrode
• 08714729995609: ORISE 3.0 mm Electrode - Kitted Device
• 08714729995593: ORISE 2.0 mm Electrode - Kitted Device
• 08714729995586: ORISE 1.5 mm Electrode - Kitted Device