FDA.reportPublic FDA data

Anesthesia Head Rest

Primary DI
00810044961638
Brand
Anesthesia Head Rest
Company
GENEVA HEALTHCARE, LLC
Model
W-TSF-1002
Catalog number
W-TSF-1002
Device description
Anesthesia Head Rest 8.5" x 8.375" > 3" x 4.5"
Published
2021-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
00810044961638PackageGS112In Commercial Distribution
00810044961645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810044961638008100449616388100449616380810044961638
00810044961645008100449616458100449616450810044961645

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810044961645Anesthesia 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
00810044961485Covered Cushions and Wedges60-300-00 60-300-00 2020-07-29

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