FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756397285
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
19-205A-00-SHA
Catalog number
19-205A-00-SHA
Device description
Shoulder Orthosis Abduction
Published
2025-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILISLING, ARM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILISling, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756397285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756397285007497563972857497563972850749756397285

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder immobilizer/orthosis, reusableA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(865)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08
00749756402682DeRoyal25-0802EU25-0802EU2026-07-08
00749756402712DeRoyal25-1108EU25-1108EU2026-07-08
00749756402729DeRoyal25-1108EUN25-1108EUN2026-07-08
00749756402736DeRoyal25-1401EU25-1401EU2026-07-08
00749756402743DeRoyal25-1401EUN25-1401EUN2026-07-08
00749756402774DeRoyal25-1403EUN25-1403EUN2026-07-08
00749756402538DeRoyal25-0101EUN25-0101EUN2026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756880282DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880299DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880312DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880329DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880336DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880343DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880930DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880947DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880954DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880961DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
06974500613616Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
06974500613623Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
16974500613613Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
16974500613620Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.ILI2025-10-17
00810113683027Shoulder Brace with Airplane KitManamed, Inc.ILI2025-09-19
00810113683034Shoulder Brace with Airplane Kit LOGOManamed, Inc.ILI2025-09-19
00190446660354PROCAREDJO, LLCILI2025-07-14
00749756397841DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-27
50749756397846DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-27
00840314811097UNIV ARM SLING W/FOAM STRAP ADULTHausmann Enterprises, LLCILI2025-01-01
M68932600100CravatSafeguard US Operating, LLCILI2024-10-09
00810113576947CoreTechVIVE HEALTH LLCILI2024-06-10
10810113576944CoreTechVIVE HEALTH LLCILI2024-06-10
00057475611026BIOS LivingThermor LtdILI2024-05-23
10057475611023BIOS LivingThermor LtdILI2024-05-23
00888912014366DONJOYDJO, LLCILI2024-02-27
07798094540061WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540078WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540085WELLBRACEPANTYMED S.A.ILI2024-01-05