FDA.reportPublic FDA data

DeRoyal

Primary DI
50749756616923
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
PAI0610P
Catalog number
PAI0610P
Device description
Prolign Back Support
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPYORTHOSIS, LUMBO-SACRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPYOrthosis, Lumbo-SacralPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756616923PackageGS110In Commercial Distribution
00749756616928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975661692350749756616923
00749756616928007497566169287497566169280749756616928

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisAn externally applied orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable 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
00854682001967ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
00854682001974ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
00854682001981ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
06974500613432Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
16974500613439Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
00810113683072Extension Panel - Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-11-25
00810113683492ManaMomma Maternity Back BraceManamed, Inc.IPY2025-10-03
00810113683508ManaMomma Maternity Back Brace, Custom Label Manamed, Inc.IPY2025-10-03
00810113683546Tailback2-50 CureTechManamed, Inc.IPY2025-10-03
00810113682709Tailback2-48Manamed, Inc.IPY2025-09-19
00810113682884Halfback2-50Manamed, Inc.IPY2025-09-19
00810113683058Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-09-19
05391512281229ACTIVDAYINDACO SRLIPY2024-02-09
05391512281236ACTIVDAYINDACO SRLIPY2024-02-09
05391512281250ACTIVDAYINDACO SRLIPY2024-02-09
05391512281267ACTIVDAYINDACO SRLIPY2024-02-09
05391512281755ACTIVDAYINDACO SRLIPY2024-02-09
05391512281762ACTIVDAYINDACO SRLIPY2024-02-09
05391512281779ACTIVDAYINDACO SRLIPY2024-02-09
05391512281786ACTIVDAYINDACO SRLIPY2024-02-09
05391512281793ACTIVDAYINDACO SRLIPY2024-02-09
05391512281809ACTIVDAYINDACO SRLIPY2024-02-09
05391512281816ACTIVDAYINDACO SRLIPY2024-02-09
05391512286026ACTIVDAYINDACO SRLIPY2024-02-09
05391512286033ACTIVDAYINDACO SRLIPY2024-02-09
05391512286057ACTIVDAYINDACO SRLIPY2024-02-09
05391512286064ACTIVDAYINDACO SRLIPY2024-02-09
05391512286095ACTIVDAYINDACO SRLIPY2024-02-09
05391512286101ACTIVDAYINDACO SRLIPY2024-02-09
05391512286118ACTIVDAYINDACO SRLIPY2024-02-09