HERMESH 7

GUDID 58032919891322

Hermesh 7 cm 8x15 is a rectangular ultra-light macroporous mesh knitted with Polypropylene monofilament, indicated for both open and laparoscopic hern

HERNIAMESH SRL

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable
Primary Device ID58032919891322
NIH Device Record Key948bbeba-7d00-44e1-be87-2105c73e32e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHERMESH 7
Version Model NumberH70815
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
GS118032919891324 [Unit of Use]
GS158032919891322 [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 Date2016-08-12

Devices Manufactured by HERNIAMESH SRL

18032919891072 - PLUG T22025-08-18 Plug T2 5 cm is a three-dimensional plug on a macroporous round base with rigid tip, indicated for the treatment of inguinal and
18032919891089 - PLUG T22025-08-18 Plug T2 7 cm is a three-dimensional plug on a macroporous round base with rigid tip, indicated for the treatment of inguinal and
18032919891065 - PLUG T22025-08-18 Plug T2 3 cm is a three-dimensional plug on a macroporous round base with rigid tip, indicated for the treatment of inguinal and
18032919891041 - PLUG T12025-08-18 Plug T1 5 cm is a macroporous round preshaped flat plug, indicated for the treatment of inguinal hernia defect with open techniq
18032919891058 - PLUG T12025-08-18 Plug T1 7 cm is a macroporous round preshaped flat plug, indicated for the treatment of inguinal hernia defect with open techniq
18032919891171 - PLUG T42025-08-18 PLUG T4 is a semi-rigid round macroporous preshaped mesh with an eccentric keyhole, indicated for the treatment of inguinal hern
18032919891829 - PLUG T42025-08-18 PLUG T4 is a standard macroporous mesh, knitted with quadriaxial technology, round shaped with an eccentric keyhole, indicated f
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

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