FDA.reportPublic FDA data

Head Cradle

Primary DI
10856446007069
Brand
Head Cradle
Company
CR ENTERPRISES, LLC
Model
10-910-02
Catalog number
10-910-02
Device description
Vinyl covered reusable Head Cradle - 4 per box
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
10856446007069PrimaryGS10
00856446007062Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085644600706910856446007069
00856446007062008564460070628564460070620856446007062

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, reusableA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position the head. This is a reusable device after appropriate cleaning.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4.7Inch
Length8Inch
Width9Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006375677
Device count
4
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
10856446007014Troop Elevation Pillow and Head Cradle10-910-0110-910-012020-04-14
10856446007045Troop Elevation Pillow Addition10-910-0510-910-052020-04-14
10856446007052Arm Board Pads for Troop Elevation Pillow10-910-0710-910-072020-04-14
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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