PROS Wedge PROS-WEDGE

GUDID 00816299012729

PROS Wedge

Hovertech International

Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use Freestanding patient positioner, single-use

• Primary Device ID: 00816299012729
• NIH Device Record Key: c19adf01-c693-4d56-9942-7f281ccc1061
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROS Wedge
• Version Model Number: PROS-WEDGE
• Catalog Number: PROS-WEDGE
• Company DUNS: 942139841
• Company Name: Hovertech International
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com
• Phone: 1(800)471-2776
• Email: spavelko@hovermatt.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816299012729 [Primary]
GS1	00816299012743 [Package]; Package: polybag [2 Units]; In Commercial Distribution
GS1	00816299012767 [Package]; Contains: 00816299012743; Package: box [5 Units]; In Commercial Distribution

FDA Product Code

• FMP: Protector, Skin Pressure

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: 2024-04-24
• Device Publish Date: 2024-04-16

Devices Manufactured by Hovertech International

• 00816299012729 - PROS Wedge: 2024-04-24PROS Wedge
• 00816299012729 - PROS Wedge: 2024-04-24 PROS Wedge
• 00816299012750 - PROS Tail: 2024-04-24 Wedge with Tail
• 00816299010213 - HoverMatt T-Burg: 2022-10-04 Trendelenburg Patient Stabilization & Air Transfer Mattress
• 00816299011685 - HoverMatt SPU Plus HoverCover: 2022-10-04 34" HoverMatt Plus HoverCover Kit
• 00816299011708 - HoverMatt SPU Plus HoverCover: 2022-10-04 HoverMatt SPU Plus HoverCover
• 00816299010237 - HoverSling Repositiong Sling-TVA: 2021-11-08 39" Single Patient Use Repositioning HoverSling Breathable TVA
• 00816299010244 - HoverSling Repositiong Sling-TVA: 2021-11-08 50" Single Patient Use Repositioning HoverSling Breathable TVA
• 00816299010404 - HoverJack: 2018-07-06 32" HoverJack