PD Synth

GUDID 08903837019646

HEALTHIUM MEDTECH LIMITED

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID08903837019646
NIH Device Record Key6106391c-ea9b-432f-b1a9-b7983ceaf460
Commercial Distribution StatusIn Commercial Distribution
Brand NamePD Synth
Version Model Number9E70DZ26
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
GS108903837019646 [Primary]

FDA Product Code

NEWSuture, Surgical, Absorbable, Polydioxanone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-24
Device Publish Date2025-02-16

On-Brand Devices [PD Synth]

089038370200489F70DZ26
089038370196469E70DZ26

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