FDA.reportPublic FDA data

Troop Elevation Pillow and Head Cradle

Primary DI
10856446007014
Brand
Troop Elevation Pillow and Head Cradle
Company
CR ENTERPRISES, LLC
Model
10-910-01
Catalog number
10-910-01
Device description
Vinyl covered reusable Troop Elevation Pillow and Head Cradle - 2 piece set
Published
2020-04-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10856446007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085644600701410856446007014

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, reusableA 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height5.75Inch
Length30Inch
Width20Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
972-625-5177rtroop@tx.rr.com

Regulatory Flags#

DUNS number
006375677
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10856446007007Disposable Troop Elevation Pillow10-910-0010-910-002020-04-14
10856446007038Disposable barrier covers for Troop Elevation Pillow10-910-0310-910-032020-04-14
10856446007090Disposable Troop Elevation Pillow Addition10-910-0410-910-042020-04-14
10856446007045Troop Elevation Pillow Addition10-910-0510-910-052020-04-14
10856446007052Arm Board Pads for Troop Elevation Pillow10-910-0710-910-072020-04-14
10856446007069Head Cradle10-910-0210-910-022020-04-14
10856446007076Troop Elevation Pillow, Addition and Head Cradle10-910-0610-910-062020-04-14
00856446007000Disposable Troop Elevation Pillow10-910-0010-910-002020-04-14
00856446007031Disposable barrier covers for Troop Elevation Pillow10-910-0310-910-032020-04-14
00856446007093Disposable Troop Elevation Pillow Addition10-910-0410-910-042020-04-14

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