FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756619196
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-1746
Catalog number
32-1746
Device description
St. Shoulder Suspension
Published
2021-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IQQJOINT, SHOULDER, EXTERNAL LIMB COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQQJoint, Shoulder, External Limb ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756619191PackageGS110In Commercial Distribution
00749756619196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975661919150749756619191
00749756619196007497566191967497566191960749756619196

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

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
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
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
00850071315509TrendOrthofix US LLCIQQ2026-04-25
00850071315516TrendOrthofix US LLCIQQ2026-04-25
00850071315486TrendOrthofix US LLCIQQ2026-04-23
00850071315493TrendOrthofix US LLCIQQ2026-04-23
00810113683539ManaEZ Shoulder Ice CureTechManamed, Inc.IQQ2025-10-03
08936235650005Fullerton Manufacturing LimitedFULLERTON MANUFACTURING LIMITEDIQQ2025-07-02
04719883461698TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463432TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
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04719883463456TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883463463TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464286TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464859TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464866TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464873TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
04719883464880TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2025-01-10
00810179880958CopperfitIdeavillage Products CorpIQQ2024-11-18
00810179880965CopperfitIdeavillage Products CorpIQQ2024-11-18
00850012035312Unite Medical®Unite Medical, LLCIQQ2024-06-20
00749756394734DeRoyalDEROYAL INDUSTRIES, INC.IQQ2024-06-06
50749756394739DeRoyalDEROYAL INDUSTRIES, INC.IQQ2024-06-06
04719883460165TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460523TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460554TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460608TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460622TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460660TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460714TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460745TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31
04719883460912TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.IQQ2023-10-31