FDA.reportPublic FDA data

Disposable barrier covers for Troop Elevation Pillow

Primary DI
00856446007031
Brand
Disposable barrier covers for Troop Elevation Pillow
Company
CR ENTERPRISES, LLC
Model
10-910-03
Catalog number
10-910-03
Device description
Disposable barrier covers for Troop Elevation Pillow and Addition - 30 per box
Published
2020-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
10856446007038PrimaryGS10
00856446007031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085644600703810856446007038
00856446007031008564460070318564460070310856446007031

GMDN Terms#

Term, Definition table
TermDefinition
Pillow cover, single-useA device made of an impermeable material that fits over a pillow, and under a pillowcase, to reduce allergen levels or for infection control. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30.5Inch
Width20.5Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006375677
Device count
30
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
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
00856446007093Disposable Troop Elevation Pillow Addition10-910-0410-910-042020-04-14

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