FDA.reportPublic FDA data

Elbow and Heel Protectors

Primary DI
10850013699169
Brand
Elbow and Heel Protectors
Company
GENEVA HEALTHCARE, LLC
Model
SYK41-223-11
Catalog number
SYK41-223-11
Device description
"Heel Boot Protector 14"" X 9"" X 1.5"""
Published
2019-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013699162PackageGS136In Commercial Distribution
10850013699169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013699162008500136991628500136991620850013699162
1085001369916910850013699169

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-262-767-9870info@genevahc.com

Regulatory Flags#

DUNS number
964459106
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810044961645Anesthesia Head Rest W-TSF-1002W-TSF-10022021-06-17
00810044961638Anesthesia Head Rest W-TSF-1002W-TSF-10022021-06-17
00810044961621Disposable Stool Medical MatGHC-1317-10DMBGHC-1317-10DMB2021-05-05
00810044961614Disposable Medical MatGHC-1830-5DMBGHC-1830-5DMB2021-05-05
10810044961628Disposable Stool Medical MatGHC-1317-10DMBGHC-1317-10DMB2021-05-05
10810044961390Packaging ProductsPSPF-CM12122PSPF-CM121222020-07-29
10810044961406Packaging ProductsPSPF-CS12122PSPF-CS121222020-07-29
10810044961475Covered Cushions and Wedges60-201-00 60-201-00 2020-07-29
10810044961598Heel & Toe Protector 130413042020-07-29
00810044961324Elbow & Heel Protector 30-111-P30-111-P2020-07-29
00810044961430Covered Cushions and Wedges60-124-CT 60-124-CT 2020-07-29
00810044961447Covered Cushions and Wedges60-100-0060-100-002020-07-29
00810044961461Covered Cushions and Wedges60-200-00 60-200-00 2020-07-29
00810044961492Covered Cushions and Wedges60-300-00 60-300-00 2020-07-29
00810044961515Covered Cushions and Wedges60-602-00 60-602-00 2020-07-29
00810044961317Elbow & Heel Protector 30-111-P30-111-P2020-07-29
00810044961379Packaging ProductsPSPF-M12124PSPF-M121242020-07-29
00810044961423Covered Cushions and Wedges60-124-CT 60-124-CT 2020-07-29
00810044961416Covered Cushions and Wedges60-100-0060-100-002020-07-29
00810044961454Covered Cushions and Wedges60-200-00 60-200-00 2020-07-29

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