FDA.reportPublic FDA data

HoverMatt T-Burg Arm Protectors

Primary DI
00816299010183
Brand
HoverMatt T-Burg Arm Protectors
Company
Hovertech International
Model
HM-TBURG-AP
Device description
Disposable foam arm protectors.
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Single use
true

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816299010183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816299010183008162990101838162990101830816299010183

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient positioning set, single-useA collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent patient sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: padded positioners dedicated to a body part such as arm, leg, shoulder, neck, or feet positioner, a headrest, a non-slip pad/bolster placed underneath the patient (e.g., cervical notch), and securing devices (e.g., straps). This is a single-use device.

Regulatory Flags#

DUNS number
942139841
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816299013191HoverSling Repositioning SheetHMSLING-39RS-HC2026-05-12
00816299013214HoverMatt SPU LinkHM39SPU-LNK-HC2026-05-12
00816299013238HoverMatt SPU LinkHM50SPU-LNK-HC2026-05-12
00816299013252HoverMatt SPU LinkHM34SPU-LNK-HC2026-05-12
00816299013276HoverSling Repositioning SheetHMSLING-50RSS-HC2026-05-12
00816299011500HoverCover SlideHMAC-SS-FULL-12026-01-12
00816299012965HoverMatt PROS AirPROS2-HM-HC2026-02-27
00816299012989HoverMatt PROS AirPROS2-HM-KIT2026-02-27
00816299013030HoverMatt PROS Air SlingPROS2-HMSL-KIT2026-02-27
00816299012958HoverMatt PROS AirPROS2-HM2026-02-27
00816299012972HoverMatt PROS AirPROS2-HM-HC2026-02-27
00816299012996HoverMatt PROS AirPROS2-HM-KIT2026-02-27
00816299013047HoverMatt PROS Air SlingPROS2-HMSL-KIT2026-02-27
00816299012194Single Patient Use HoverMattRGMT50FL-REGRGMT50FL-REG2023-01-16
00816299013016HoverMatt PROS Air SlingPROS2-HMSL2026-01-12
00816299011517HoverCover FittedHMAC-FIT-30-12026-01-12
00816299012828HoverMatt PROSWedgePROSXL2026-01-12
00816299012934HoverCover Three-QTRHMAC-2002026-01-12
00816299010213HoverMatt T-BurgHM-TBURG-34HM-TBURG-342022-09-26
00816299010077HoverMattHM39DCHM39DC2016-07-30

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00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
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