Surgical Mesh

GUDID 08903837165985

HEALTHIUM MEDTECH LIMITED

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Primary Device ID08903837165985
NIH Device Record Key659ad61d-6f93-442e-8649-891c40293b79
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgical Mesh
Version Model NumberTVM151-IB
Company DUNS916326705
Company NameHEALTHIUM MEDTECH LIMITED
Device Count1
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
GS108903837165978 [Primary]
GS108903837165985 [Package]
Contains: 08903837165978
Package: [3 Units]
In Commercial Distribution

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-08
Device Publish Date2023-08-31

On-Brand Devices [Surgical Mesh]

08903837165985TVM151-IB
08903837165961TVM303-IB

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