BOOST 00711654

GUDID 10724995184053

The Boost head positioner helps to stabilize a patient's head during ERCP and other gastrointestinal endoscopy procedures.

US Endoscopy

Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use Freestanding headrest, single-use

• Primary Device ID: 10724995184053
• NIH Device Record Key: cf07d42b-bb29-410b-9024-1d4e6823fe70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOOST
• Version Model Number: 00711654
• Catalog Number: 00711654
• Company DUNS: 627879687
• Company Name: US Endoscopy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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
• 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
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995184056 [Primary]
GS1	10724995184053 [Package]; Contains: 00724995184056; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• LWG: SURGICAL TABLE CUSHION

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: 2021-04-08
• Device Publish Date: 2021-03-31

Devices Manufactured by US Endoscopy

• 00724995227340 - NA: 2023-11-21 gi400 Electrosurgery Unit Evaluation Kit
• 00724995199296 - truFreeze: 2023-07-19 truFreeze Spray Cryotherapy System Console allows for delivery of liquid nitrogen (LN2) during both active and passive venting p
• 20724995221618 - Ascendo: 2023-07-19 Ascendo Submucosal Lifting Agent
• 10724995216839 - Torrent: 2023-05-15 The Torrent irrigation scope connector is used with the Torrent irrigation tubing to provide irrigation fluids such as sterile w
• 50724995216844 - Torrent: 2023-05-15 The Torrent irrigation scope connector Pentax is used with the Torrent irrigation tubing to provide irrigation fluids such as st
• 50724995220681 - Assurance: 2023-03-30 The Assurance Clip - 11 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purp
• 10724995220690 - Assurance: 2023-03-30 The Assurance Clip -16 mm is compatible with endoscopes and is indicated for clip placement within digestive tract for the purpo
• 10724995211537 - UroSeal: 2022-12-06 The UroSeal Adjustable Endoscopic Valve is used to resist the backflow of fluid around an instrument inserted through the workin