FDA.report

Abdominal Binder

Primary DI
00616784438238
Brand
Abdominal Binder
Company
DYNAREX CORPORATION
Model
4382
Device description
Abdominal Binder, Large, 12", Fits 36"-42" waist
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSDBinder, Abdominal

Product Code Classifications

CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784438238PackageGS110In Commercial Distribution
00616784438221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784438238006167844382386167844382380616784438238
00616784438221006167844382216167844382210616784438221

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

Other Devices Sharing Product Codes

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