FDA.report

Phasix Plug and Patch

Primary DI
00801741010613
Brand
Phasix Plug and Patch
Company
Davol Inc.
Model
1190601
Catalog number
1190601
Device description
Phasix Plug and Patch Medium
Published
2015-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OWTMesh, surgical, absorbable, abdominal hernia

Product Code Classifications

CodeDeviceSpecialtyClass
OWTMesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741010613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741010613008017410106138017410106130801741010613

GMDN Terms

TermDefinition
Multi-purpose surgical mesh, synthetic polymer, bioabsorbableA sterile, flat, or three-dimensional (3-D), woven/knitted or porous implantable device made of a bioabsorbable synthetic polymer [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Height1.3Inch
Height3.3Centimeter
Outer Diameter1.6Inch
Outer Diameter4.06Centimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature086 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)562-0027medical.services@bd.com

Regulatory Flags

DUNS number
001191048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00801741233678GalaFLEXGP0103BDGP0103BD2025-09-25
00801741233685GalaFLEXGP0206BDGP0206BD2025-09-25
00801741233692GalaFLEXGP0208BDGP0208BD2025-09-25
00801741233708GalaFLEXGP0408BDGP0408BD2025-09-25
00801741233715GalaFLEXGP0608BDGP0608BD2025-09-25
00801741233722GalaFLEX LITEGFLT0207BDGFLT0207BD2025-09-25
00801741233739GalaFLEX LITEGFLT0515BDGFLT0515BD2025-09-25
00801741233746GalaFLEX LITEGFLT0520BDGFLT0520BD2025-09-25
00801741233753GalaFLEX LITEGFLT0013BDGFLT0013BD2025-09-25
00801741233760GalaFLEX LITEGFLT1020BDGFLT1020BD2025-09-25
00801741233777GalaFLEX LITEGFLT0015BDGFLT0015BD2025-09-25
00801741233784GalaFLEX LITEGFLT0017BDGFLT0017BD2025-09-25
00801741233791GalaFLEX LITEGFLT1520BDGFLT1520BD2025-09-25
00801741233814GalaFLEX LITEGFLT0019BDGFLT0019BD2025-09-25
00801741233821GalaFLEX LITEGFLT0022BDGFLT0022BD2025-09-25
00801741233838GalaFLEX LITEGFLT0025BDGFLT0025BD2025-09-25
00801741233852GalaFLEX LITEGFLT2025BDGFLT2025BD2025-09-25
00801741234019GalaFLEX LITEGFLT2530BDGFLT2530BD2025-09-25
00801741226519Phasix123000712300072025-02-24
00801741226533Phasix123000912300092025-02-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07332999000222TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
00801741226519PhasixDavol Inc.OWT2025-02-24
00801741226533PhasixDavol Inc.OWT2025-02-24
00801741226571PhasixDavol Inc.OWT2025-02-24
10884521809703TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10884521809710TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10884521809727TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10884521809734TransorbSOFRADIM PRODUCTIONOWT2024-03-08
10653405988939BioBraceConmed CorporationOWT2024-02-12
10653405988953BioBraceConmed CorporationOWT2024-02-12
10653405988960BioBraceConmed CorporationOWT2024-02-12
00860006566708BioBrace 5mmBiorez, Inc.OWT2021-05-24
00801741161216Phasix™ ST Mesh with Echo 2™ Positioning SystemDavol Inc.OWT2019-07-12
00801741161223Phasix™ ST Mesh with Echo 2™ Positioning SystemDavol Inc.OWT2019-07-12
00801741163234Phasix™ ST Mesh with Open Positioning SystemDavol Inc.OWT2019-06-19
00801741163241Phasix™ ST Mesh with Open Positioning SystemDavol Inc.OWT2019-06-19
00733132644568GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWT2018-09-28
00733132644575GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWT2018-09-28
00733132644605GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWT2018-09-28
00733132644629GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWT2018-09-28
00733132644643GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWT2018-09-28
00733132644650GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OWT2018-09-28
00733132644698GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OWT2018-09-28
00733132644711GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OWT2018-09-28
H373FS080834GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWT2017-02-13
00733132605446GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWT2017-02-13
00733132606139GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OWT2017-02-13
00733132606146GORE BIO-A Hernia PlugW. L. Gore & Associates, Inc.OWT2017-02-13
00801741095306Phasix ST MeshDavol Inc.OWT2015-08-05
00801741095320Phasix ST MeshDavol Inc.OWT2015-08-05