FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756796441
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
103N20
Catalog number
103N20
Device description
CONTOURED CERVICAL COLLAR
Published
2021-07-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQKOrthosis, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756796441PackageGS112In Commercial Distribution
00749756796446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975679644150749756796441
00749756796446007497567964467497567964460749756796446

GMDN Terms#

Term, Definition table
TermDefinition
Cervical spine collar, single-useA padded device that is worn around the neck and used to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16946430425079Lightning X Products, IncXIAMEN COMPOWER MEDICAL TECH. CO., LTDIQK2025-12-24
16974500613606 Cervical CollarGCMEDICA ENTERPRISE LTD.(WUXI)IQK2025-12-12
00749756399395DeRoyalDEROYAL INDUSTRIES, INC.IQK2025-07-23
00749756399401DeRoyalDEROYAL INDUSTRIES, INC.IQK2025-07-23
10810113578801ViveVIVE HEALTH LLCIQK2025-07-08
04823097718131TM "Rehabilitimed" ORTEZ-2V-1 XL-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718148TM "Rehabilitimed" ORTEZ-2V-1 XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718155TM "Rehabilitimed" ORTEZ-2V-1 XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097718162TM "Rehabilitimed" ORTEZ-2V-1 L-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718179TM "Rehabilitimed" ORTEZ-2V-1 L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718186TM "Rehabilitimed" ORTEZ-2V-1 L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097718193TM "Rehabilitimed" ORTEZ-2V-1 M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097718209TM "Rehabilitimed" ORTEZ-2V-1 M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097718216TM "Rehabilitimed" ORTEZ-2V-1 M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719701TM "Rehabilitimed" ORTEZ-2V-1 M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719718TM "Rehabilitimed" ORTEZ-2V-1 L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719725TM "Rehabilitimed" ORTEZ-2V-1 XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719732TM "Rehabilitimed" ORTEZ-2V-1 M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719749TM "Rehabilitimed" ORTEZ-2V-1 L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719756TM "Rehabilitimed" ORTEZ-2V-1 XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719763TM "Rehabilitimed" ORTEZ-2V-1 M-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719770TM "Rehabilitimed" ORTEZ-2V-1 L-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719787TM "Rehabilitimed" ORTEZ-2V-1 XL-110 ComfortREABILITIMED TOVIQK2025-05-04
04823097719909TM "Rehabilitimed" ORTEZ-2V M-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719916TM "Rehabilitimed" ORTEZ-2V L-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719923TM "Rehabilitimed" ORTEZ-2V XL-75 ComfortREABILITIMED TOVIQK2025-05-04
04823097719930TM "Rehabilitimed" ORTEZ-2V M-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719947TM "Rehabilitimed" ORTEZ-2V L-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719954TM "Rehabilitimed" ORTEZ-2V XL-90 ComfortREABILITIMED TOVIQK2025-05-04
04823097719961TM "Rehabilitimed" ORTEZ-2V M-110 ComfortREABILITIMED TOVIQK2025-05-04