HERTRA 2A

GUDID 58032919890882

Hertra 2A cm 4,5x10 is a semirigid pre-shaped mesh without hole knitted with Polypropylene monofilament, indicated in females, for the open repair of

HERNIAMESH SRL

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Primary Device ID58032919890882
NIH Device Record Key58d4f1d7-d6f3-4c68-a52a-ed1452b9fb6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHERTRA 2A
Version Model NumberHTR2A
Company DUNS459310140
Company NameHERNIAMESH SRL
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118032919890884 [Unit of Use]
GS158032919890882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2016-08-02

Devices Manufactured by HERNIAMESH SRL

18032919890259 - HERTRA KIT2024-04-02 Kit #3 includes a semirigid pre-shaped mesh with hole knitted with Polypropylene monofilament and a tridimensional plug with a r
18032919891362 - HERTRA2024-04-02 Hertra 6 cm 5,5x13 is a light macroporous pre-shaped mesh, with hole, knitted with Polypropylene monofilament, indicated for the
18032919890112 - HERTRA KIT2023-07-24 Kit #1 includes a macroporous rigid preshaped mesh with keyhole opening and a three-dimensional plug on a macroporous round base
18032919890129 - HERTRA KIT2023-07-24 Kit #2 includes a macroporous rigid preshaped mesh with keyhole opening and a three-dimensional plug on a macroporous round base
18032919891881 - PLUG T22023-07-24 Plug T2 5 cm is a macroporous three-dimensional plug on a round base, indicated for treatment of inguinal and femoral hernia def
18032919891898 - PLUG T22023-07-24 Plug T2 7 cm is a macroporous three-dimensional plug on a round base, indicated for treatment of inguinal and femoral hernia def
18032919891874 - PLUG T22023-07-24 Plug T2 3 cm is a macroporous three-dimensional plug on a round base, indicated for treatment of inguinal and femoral hernia def
18032919891683 - HERTRA2023-07-24 Hertra 9 5x11 cm is a macroporous preshaped mesh with keyhole opening, indicated for the treatment of inguinal hernia defects wi
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