Trulene Mesh

GUDID 08903837066978

HEALTHIUM MEDTECH LIMITED

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
Primary Device ID08903837066978
NIH Device Record Keyc6a38b37-88db-4ff3-adf8-fee557b816f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrulene Mesh
Version Model NumberTMM151
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108903837066978 [Primary]

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 Number2
Public Version Date2025-08-18
Device Publish Date2024-07-11

On-Brand Devices [Trulene Mesh]

08903837067203TVLM303
08903837105042TVLM151
08903837067401TVM715
08903837067388TVM611
08903837067340TVM303
08903837067326TVM151
08903837067036TMM715
08903837066978TMM151

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.