00711847

GUDID 00816765012086

The Bipolar Hemostatic Probe is passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract.

US Endoscopy

Endoscopic electrosurgical electrode, bipolar, single-use

• Primary Device ID: 00816765012086
• NIH Device Record Key: 5f9ce875-a80d-474e-8251-d5fdd0a9b370
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 00711847
• Catalog Number: 00711847
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter
• Outer Diameter: 3.3 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816765012086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102273

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: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-09-17

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