FDA.report

DeRoyal

Primary DI
00749756063494
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
BS1000-12
Catalog number
BS1000-12
Device description
WORKERS BACK SUPPORT
Published
2021-08-03
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

Related Records

Contact Domains

Product Codes

CodeName
IPYORTHOSIS, LUMBO-SACRAL

Product Code Classifications

CodeDeviceSpecialtyClass
IPYOrthosis, Lumbo-SacralPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00749756063494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756063494007497560634947497560634940749756063494

GMDN Terms

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

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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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

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00810113682709Tailback2-48Manamed, Inc.IPY2025-09-19
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00810113683058Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-09-19
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05391512286057ACTIVDAYINDACO SRLIPY2024-02-09
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05391512286095ACTIVDAYINDACO SRLIPY2024-02-09
05391512286101ACTIVDAYINDACO SRLIPY2024-02-09
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05391512286132ACTIVDAYINDACO SRLIPY2024-02-09
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05391512286019ACTIVDAYINDACO SRLIPY2024-01-31
05391512286040ACTIVDAYINDACO SRLIPY2024-01-31
05391512286071ACTIVDAYINDACO SRLIPY2024-01-31
05391512286088ACTIVDAYINDACO SRLIPY2024-01-31
05391512286217M-Brace AirINDACO SRLIPY2024-01-30
05391512286224M-Brace AirINDACO SRLIPY2024-01-30
05391512286231M-Brace AirINDACO SRLIPY2024-01-30
05391512286255M-Brace AirINDACO SRLIPY2024-01-30