FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756796489
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
105N30
Catalog number
105N30
Device description
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

Related Records

Contact Domains

Product Codes

CodeName
IQKOrthosis, cervical

Product Code Classifications

CodeDeviceSpecialtyClass
IQKOrthosis, CervicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50749756796489PackageGS112In Commercial Distribution
00749756796484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975679648950749756796489
00749756796484007497567964847497567964840749756796484

GMDN Terms

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

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

Other Devices From This Company

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 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