FDA.reportPublic FDA data

ULTRAPRO COMFORT PLUG

Primary DI
10705031228474
Brand
ULTRAPRO COMFORT PLUG
Company
Johnson & Johnson International Inc.
Model
UPLUG553
Catalog number
UPLUG553
Device description
Partially Absorbable Hernia Repair Device
Published
2019-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, surgical, polymeric

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031228471PackageGS13In Commercial Distribution
10705031228474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503122847120705031228471
1070503122847410705031228474

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, composite-polymerA partially-bioabsorbable, implantable material (e.g., flat sheet) made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Storage Environment Temperature030 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
372587696
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031038783Coated VICRYLJ322HJ322H2015-09-01
10705031038806Coated VICRYLJ323HJ323H2015-09-01
10705031039131Coated VICRYLJ347HJ347H2015-09-23
10705031039292Coated VICRYLJ363HJ363H2015-09-23
10705031038653Coated VICRYLJ306HJ306H2015-09-01
10705031038738Coated VICRYLJ316HJ316H2015-09-01
10705031038875Coated VICRYLJ329HJ329H2015-09-01
10705031038950Coated VICRYLJ335HJ335H2015-09-01
10705031039278Coated VICRYLJ359HJ359H2015-09-01
10705031039315Coated VICRYLJ364HJ364H2015-09-01
10705031039339Coated VICRYLJ365HJ365H2015-09-01
10705031039391Coated VICRYLJ371HJ371H2015-09-01
10705031039704Coated VICRYLJ418HJ418H2015-09-01
10705031040076Coated VICRYLJ459HJ459H2015-09-01
10705031040090Coated VICRYLJ460HJ460H2015-09-01
10705031040113Coated VICRYLJ461HJ461H2015-09-01
10705031040199Coated VICRYLJ467HJ467H2015-09-01
10705031040298Coated VICRYLJ474HJ474H2015-09-01
10705031040397Coated VICRYLJ486HJ486H2015-09-01
10705031040595Coated VICRYLJ496HJ496H2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970461300015TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
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