FDA.report

N/A

Primary DI
00614138100015
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
124114
Catalog number
124114
Device description
ABDOMINAL BINDER 10IN XLARGE
Published
2022-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSDBinder, Abdominal

Product Code Classifications

CodeDeviceSpecialtyClass
FSDBinder, AbdominalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614138100015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614138100015006141381000156141381000150614138100015

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

Contacts

PhoneEmail
18006214041sales@tetramed.com

Regulatory Flags

DUNS number
047580212
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00614138016040N/A1212021212022022-08-19
00614138016057N/A1212031212032022-08-19
00614138016064N/A1212041212042022-08-19
00614138016071N/A1212051212052022-08-19
00614138016088N/A1212061212062022-08-19
00614138025332N/A12007P12007P2022-08-19
00614138025349N/A12007N12007N2022-08-19
00614138105119N/A1214101214102022-08-19
00614138105126N/A1214111214112022-08-19
00614138105133NA1214121214122022-08-19
00614138105140N/A1214131214132022-08-19
00614138105157N/A1214141214142022-08-19
00614138105164N/A1214151214152022-08-19
00614138106147N/A1213021213022022-08-19
00614138106161N/A1213041213042022-08-19
00614138113428N/A2149-012149-012022-08-19
00614138113435N/A2149-022149-022022-08-19
00614138113442N/A2149-032149-032022-08-19
00614138113459N/A2149-042149-042022-08-19
00614138113466N/A2149-062149-062022-08-19

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