FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756351817
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
RC-525SM
Catalog number
RC-525SM
Device description
RIGID COLLAR
Published
2021-08-10
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
50749756351817PackageGS110In Commercial Distribution
00749756351812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975635181750749756351817
00749756351812007497563518127497563518120749756351812

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
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071315226TrendOrthofix US LLCIQK2026-04-25
00850071315233TrendOrthofix US LLCIQK2026-04-14
00749756879699DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879705DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879712DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879729DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879736DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879750DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879767DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879774DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879804DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879811DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879828DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879835DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879989DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756879996DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880008DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880084DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880091DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756880107DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887601DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887618DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887625DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887632DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887649DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887656DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887687DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887694DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887700DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02
00749756887717DeRoyalDEROYAL INDUSTRIES, INC.IQK2026-04-02