TRUGLYDE

GUDID 08903837025562

HEALTHIUM MEDTECH LIMITED

Skin-closing tension device
Primary Device ID08903837025562
NIH Device Record Keycf624c5d-9c00-47bd-b0bc-2f68fc1a408c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUGLYDE
Version Model Number2F45CX19
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
GS108903837025562 [Primary]

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-16
Device Publish Date2024-07-08

On-Brand Devices [TRUGLYDE]

089038370406192E70EZ26.5-6
089038370270612H45CX19
089038370265692G45CX19
089038370255622F45CX19
089038372461102H45CX13P
089038370245412E70DZ30

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