FDA.reportPublic FDA data

N/A

Primary DI
00614138003798
Brand
N/A
Company
TETRA MEDICAL SUPPLY CORP.
Model
125104
Catalog number
125104
Device description
DELUXE ABDOMINAL BINDER 12IN XLARGE
Published
2022-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00614138003798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614138003798006141380037986141380037980614138003798

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18006214041sales@tetramed.com

Regulatory Flags#

DUNS number
047580212
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614138106147N/A1213021213022022-08-19
00614138106161N/A1213041213042022-08-19
00614138107786N/A1299041299042022-08-09
00614138101203N/A2822002822002022-08-02
00614138114302N/A2824002824002022-08-02
00614138114258N/A2812-002812-002022-08-01
00614138114272N/A2816002816002022-08-01
00614138114289N/A2820002820002022-08-01
00614138107809N/A1299111299112022-07-29
00614138107816N/A1299121299122022-07-29
00614138107823N/A1299131299132022-07-29
00614138107830N/A1299141299142022-07-29
00614138121799N/A1458001458002022-07-30
00614138121805N/A1458011458012022-07-30
00614138121812N/A1458021458022022-07-30
00614138121829N/A1458031458032022-07-30
00614138121836N/A1458041458042022-07-30
00614138121843N/A1458101458102022-07-30
00614138121850N/A1458111458112022-07-30
00614138121867N/A1458121458122022-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06975740362203MomcozyShenzhen Root Innovation 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