PROS Wedge PROS-WEDGE

GUDID 00816299012729

PROS Wedge

Hovertech International

Freestanding patient positioner, single-use
Primary Device ID00816299012729
NIH Device Record Keyc19adf01-c693-4d56-9942-7f281ccc1061
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROS Wedge
Version Model NumberPROS-WEDGE
Catalog NumberPROS-WEDGE
Company DUNS942139841
Company NameHovertech International
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com
Phone1(800)471-2776
Emailspavelko@hovermatt.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816299012729 [Primary]
GS100816299012743 [Package]
Package: polybag [2 Units]
In Commercial Distribution
GS100816299012767 [Package]
Contains: 00816299012743
Package: box [5 Units]
In Commercial Distribution

FDA Product Code

FMPProtector, Skin Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-24
Device Publish Date2024-04-16

Devices Manufactured by Hovertech International

00816299011647 - Q2 Roller Lateral Turning Device2024-09-05 Q2Roller w/ 5 pack of chux
00816299011586 - Q2Roller® Lateral Turning Device2024-08-30 Q2Roller Lateral Turning Device
00816299012729 - PROS Wedge2024-04-24PROS Wedge
00816299012729 - PROS Wedge2024-04-24 PROS Wedge
00816299012750 - PROS Tail2024-04-24 Wedge with Tail
00816299010213 - HoverMatt T-Burg2022-10-04 Trendelenburg Patient Stabilization & Air Transfer Mattress
00816299011685 - HoverMatt SPU Plus HoverCover2022-10-04 34" HoverMatt Plus HoverCover Kit
00816299011708 - HoverMatt SPU Plus HoverCover2022-10-04 HoverMatt SPU Plus HoverCover
00816299010237 - HoverSling Repositiong Sling-TVA2021-11-08 39" Single Patient Use Repositioning HoverSling Breathable TVA

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