Endo-Boot 00711621

GUDID 20724995184012

The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other surgical instruments during storage and transport.

US Endoscopy

Surgical instrument guard, single-use, sterile

• Primary Device ID: 20724995184012
• NIH Device Record Key: f0f0fec8-20ca-4bcb-819b-2fc1f6cd5443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Boot
• Version Model Number: 00711621
• Catalog Number: 00711621
• Company DUNS: 627879687
• Company Name: US Endoscopy
• Device Count: 25
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995184018 [Unit of Use]
GS1	10724995184015 [Primary]
GS1	10816765013417 [Previous]
GS1	20724995184012 [Package]; Contains: 10724995184015; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951104

FDA Product Code

• OCU: Endoscopic storage cover

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-09
• Device Publish Date: 2020-04-01

On-Brand Devices [Endo-Boot]

• 20816765013421: The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other
• 20816765013414: The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other
• 20724995184029: The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other
• 20724995184012: The Endo-Boot tip protector is used as a protective cover for the tip of the endoscope or other