FDA.reportPublic FDA data

Kendall

Primary DI
20884521177311
Brand
Kendall
Company
Cardinal Health, Inc.
Model
31310P
Catalog number
31310P
Device description
True content to be populated as part of rebranding
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
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
20884521177311PackageGS150Not in Commercial Distribution
10884521177314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452117731120884521177311
1088452117731410884521177314

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal binder, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
DM exempt
false
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

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