FDA.reportPublic FDA data

Abdominal Binder

Primary DI
00616784438320
Brand
Abdominal Binder
Company
Dynarex Corporation
Model
4383
Device description
"Abdominal Binder, XLarge, 12"", Fits 42""-48"" waist"
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00616784438337PackageGS110In Commercial Distribution
00616784438320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784438337006167844383376167844383370616784438337
00616784438320006167844383206167844383200616784438320

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, reusableA strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
00840117339088Durma+ Transparent Film Dressing, Frame Style36482024-12-13
00616784319438Compress Bandages, Offset, Sterile31942021-06-21
00840117307360Child Face Masks2207-CHCR2021-06-21
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01
00616784316925Cotton Balls, Large31692026-10-01
00616784317021Cotton Balls, Medium31702026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67172026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
00840117346147Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Toggle Valve, 4.55 L36390-TBULK2026-09-28
00840117346154Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Toggle Valve36391-TBULK2026-09-28
00840117346239Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Post Valve36391-PBULK2026-09-28
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister324092026-09-25
00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
00840117352742dmecare Solutions Elongated Folding Bedside Commode103712021-04-22
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01

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
06975740361312MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
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
06975740361572MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
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
06975740361626MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361633MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361640MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361657MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361664MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361671MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
06975740361688MomcozyShenzhen Root Innovation Technology Co., Ltd.FSD2025-07-29
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