FDA.report

Phasix Plug and Patch

Primary DI
00801741010637
Brand
Phasix Plug and Patch
Company
Davol Inc.
Model
1190603
Catalog number
1190603
Device description
Phasix Plug and Patch Extra Large
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
OODsurgical film

Product Code Classifications

CodeDeviceSpecialtyClass
OODSurgical FilmGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00801741010637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00801741010637008017410106378017410106370801741010637

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
Height1.4Inch
Height3.56Centimeter
Outer Diameter2Inch
Outer Diameter5.08Centimeter

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

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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
00801741233678GalaFLEXDavol Inc.OOD2025-09-25
00801741233685GalaFLEXDavol Inc.OOD2025-09-25
00801741233692GalaFLEXDavol Inc.OOD2025-09-25
00801741233708GalaFLEXDavol Inc.OOD2025-09-25
00801741233715GalaFLEXDavol Inc.OOD2025-09-25
00801741233722GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233739GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233746GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233753GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233760GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233777GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233784GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233791GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233814GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233821GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233838GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741233852GalaFLEX LITEDavol Inc.OOD2025-09-25
00801741234019GalaFLEX LITEDavol Inc.OOD2025-09-25
00810054980797GalaFLEX LITETepha, Inc.OOD2023-07-26
00810054980803GalaFLEX LITETepha, Inc.OOD2023-07-26
00810054980810GalaFLEX LITETepha, Inc.OOD2023-07-26
00810054980827GalaFLEX LITETepha, Inc.OOD2023-07-26
00810054980544GalaFLEX LITETepha, Inc.OOD2021-07-20
00810054980551GalaFLEX LITETepha, Inc.OOD2021-07-20
00810054980568GalaFLEX LITETepha, Inc.OOD2021-07-20
00810054980575GalaFLEX LITETepha, Inc.OOD2021-07-20
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00810054980599GalaFLEX LITETepha, Inc.OOD2021-07-20
00810054980605GalaFLEX LITETepha, Inc.OOD2021-07-20
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