FDA.reportPublic FDA data

RENASYS AB DRSG KIT W/SOFTPORT

Primary DI
00040565127255
Brand
RENASYS AB DRSG KIT W/SOFTPORT
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66021980
Catalog number
66021980
Device description
Renasys Abdominal Dressing Kit with Soft Port
Published
2020-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143133000RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port DeviceSmith & Nephew, Inc.2015-07-23OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30040565127256PackageGS15In Commercial Distribution
00040565127255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3004056512725630040565127256
00040565127255000405651272550405651272550040565127255

GMDN Terms#

Term, Definition table
TermDefinition
Wound dressing kit, medicatedA collection of instruments, dressings, and pharmaceuticals intended to be used to dress a wound. Items typically include scissors, forceps, gauze, cotton-tip applicators, and antiseptics. This is a single-use device.

Regulatory Flags#

DUNS number
216344051
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05000223503284ACTICOAT Flex66027689660276892026-08-25
05000223503697ACTICOAT Flex66027691660276912026-08-25
05000223482589CICA CARE66801491668014912026-04-30
05000223502157CICA CARE66803184668031842026-04-30
05000223502270ACTICOAT Flex66027686660276862026-04-29
05000223502300ACTICOAT Flex66027687660276872026-04-29
05000223502331ACTICOAT Flex66027688660276882026-04-29
05000223502249ACTICOAT Flex66027685660276852026-04-28
05000223502218ACTICOAT FLEX66027684660276842026-03-26
05000223503727ACTICOAT Flex66027683660276832026-03-26
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117737COVRSITE5971430059714300 / 597144002026-01-19
00040565117690COVRSITE5971400059714000 / 597141002026-01-19
00040565120249COVRSITE59715000597150002026-01-19
00040565120263COVRSITE59715100597151002026-01-19
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19
00040565120270COVRSITE59715100597151002026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06970461300022TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300039TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300046TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300053TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300060TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300077TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300084TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300091TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300107TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300114TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300121TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300138TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300145TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300152TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300169TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300176TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300183TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300190TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300206TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300213TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300220TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300237TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300244TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300251TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300268TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300275TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300282TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300299TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300305TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22