FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756112994
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
M5001-XXL
Catalog number
M5001-XXL
Device description
SURGICAL BRA
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

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
00749756112994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756112994007497561129947497561129940749756112994

GMDN Terms#

Term, Definition table
TermDefinition
Postsurgical brassiere, non-antimicrobialA woman's undergarment designed to support and/or contour the breast(s) after surgical intervention (e.g., thoracic surgery, mastectomy, lumpectomy); it may also be intended for use during medical treatment (e.g., chemotherapy). It may also be referred to as bra, and is specifically designed for patient support/comfort in the home or healthcare facility; it does not include antimicrobial features. 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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975740361312MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361336MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361343MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361565MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361572MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361589MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361596MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361602MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361619MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361626MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361633MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361640MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361657MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361664MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361671MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361688MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361978MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361985MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740361992MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362005MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362173MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-29
06975740362180MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
06975740362197MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
06975740362203MomcozyShenzhen Lutejiacheng Technology Co., Ltd.FSD2025-07-28
00190446660217PROCAREDJO, LLCFSD2025-05-14
00190446660279PROCAREDJO, LLCFSD2025-05-14
00190446660286PROCAREDJO, LLCFSD2025-05-14
00190446660293PROCAREDJO, LLCFSD2025-05-14
00190446660750PROCAREDJO, LLCFSD2025-05-14
00190446660767PROCAREDJO, LLCFSD2025-05-14