FDA.report

DeRoyal

Primary DI
00749756022767
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
9222-00
Catalog number
9222-00
Device description
Tension Pillow
Published
2021-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CCXSUPPORT, PATIENT POSITION

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756022767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756022767007497560227677497560227670749756022767

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
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50749756401352DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22
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