FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756268912
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
13760300
Catalog number
13760300
Device description
RIB BELT
Published
2021-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSDBINDER, ABDOMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756268912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756268912007497562689127497562689120749756268912

GMDN Terms#

Term, Definition table
TermDefinition
Rib/sternum binder, single-useA strip or roll of fabric or plastic material designed to support the sternum (the breastbone), ribs, and chest (e.g., to support a sternum/rib fracture or support the chest post cardiothoracic surgery). It may be referred to as a chest binder or sternum splint. 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
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
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756880398DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880404DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880411DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880428DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756880435DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756888417DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
00749756888424DeRoyalDEROYAL INDUSTRIES, INC.FSD2026-04-02
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06975740361336MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361343MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361565MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
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06975740361589MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361596MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361602MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361619MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
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06975740361671MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
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06975740361978MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361985MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361992MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740362005MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740362173MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740362180MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-28
06975740362197MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-28