FDA.reportPublic FDA data

PROLENE

Primary DI
10705031049062
Brand
PROLENE
Company
ETHICON, LLC
Model
PMXL
Catalog number
PMXL
Device description
Polypropylene Non-absorbable Synthetic Surgical Mesh
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
20705031049069PackageGS16In Commercial Distribution
10705031049062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503104906920705031049069
1070503104906210705031049062

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbableA sterile, flat or three-dimensional (3-D), woven/knitted or porous material made of one or more non-bioabsorbable synthetic polymers [e.g., polypropylene, polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
829465157
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30705031242573Coated VICRYLJB947HJB947H2026-02-18
30705031242580Coated VICRYLJB977HJB977H2026-02-18
30705031054602VICRYLVCP644TVCP644T2026-02-09
30705031470624PDSPDP422ZHPDP422ZH2026-01-29
30705031045600PROLENEM821CM821C2026-01-07
30705031049097PRONOVAPN489GPN489G2026-01-07
30705031049103PRONOVAPN496GPN496G2026-01-07
30705031049172PRONOVAPN584GPN584G2026-01-07
30705031246175PRONOVAPN3558HPN3558H2026-01-07
30705031097234PROLENEEH7583HEH7583H2025-11-11
30705031098439PROLENEEH7835HEH7835H2025-11-11
30705031116201PROLENEF1880F18802025-11-11
30705031098477PROLENEEH7897GEH7897G2025-04-22
30705031228348PROLENEEP8729HEP8729H2025-04-22
30705031228621PROLENEEP8767HEP8767H2025-04-22
30705031237807PROLENEW753GW753G2025-04-22
30705031050864ETHICONTPW10TPW102015-09-24
10705031050877ETHICONTPW20TPW202015-09-01
10705031050884ETHICONTPW30TPW302015-09-01
10705031050891ETHICONTPW32TPW322015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521179004ParieteneSOFRADIM PRODUCTIONFTL2026-01-16
10884521179035ParieteneSOFRADIM PRODUCTIONFTL2026-01-16
10884521179042ParieteneSOFRADIM PRODUCTIONFTL2026-01-16
10884521179059ParieteneSOFRADIM PRODUCTIONFTL2026-01-16
10884521179066ParieteneSOFRADIM PRODUCTIONFTL2026-01-16
10884521179073ParieteneSOFRADIM PRODUCTIONFTL2026-01-16
10884521179028ParieteneSOFRADIM PRODUCTIONFTL2026-01-15
09421907331881OviTex® CoreAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331935OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331942OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331959OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421907331973OviTex® 1SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222065OviTex® 2SAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222096OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222102OviTex® Low ProfileAROA BIOSURGERY LIMITEDFTL2025-11-26
09421908222157OviTex® InguinalAROA BIOSURGERY LIMITEDFTL2025-11-26
07332999000239TIGR® Matrix Surgical MeshNovus Scientific ABFTL2025-08-29
07332999000246TIGR® Matrix Surgical MeshNovus Scientific ABFTL2025-08-29
07332999000468TIGR® Matrix Surgical MeshNovus Scientific ABFTL2025-08-29
07332999000475TIGR® Matrix Surgical MeshNovus Scientific ABFTL2025-08-29
00810057380006SurgiWrap FROSTMAST BIOSURGERY USA INC.FTL2025-08-21
00810057380013SurgiWrap FROSTMAST BIOSURGERY USA INC.FTL2025-08-21
00810057380020SurgiWrap FROSTMAST BIOSURGERY USA INC.FTL2025-08-21
05060267134271SIC GraftXIROS LTDFTL2025-08-07
05060267134493Infinity-Lock 3XIROS LTDFTL2025-08-07
05060267134509Infinity-Lock 5XIROS LTDFTL2025-08-07
10888867301938Arthrex®ARTHREX, INC.FTL2025-06-13
00888867301948Arthrex®ARTHREX, INC.FTL2025-06-13
06975222391011SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.FTL2025-05-20
05060267134301AchilloCordPLUSXIROS LTDFTL2025-03-26