Monoglyde

GUDID 08903837149282

HEALTHIUM MEDTECH LIMITED

Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID08903837149282
NIH Device Record Keyf8c60454-5a94-4daa-ba85-6bdd2891649b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonoglyde
Version Model Number11H90CY16
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
GS108903837149275 [Primary]
GS108903837149282 [Package]
Contains: 08903837149275
Package: [12 Units]
In Commercial Distribution

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 Date2023-09-15
Device Publish Date2023-09-07

On-Brand Devices [Monoglyde]

0890383714924411F90CY19
0890383714928211H90CY16
0890383714926811G90CY16
0890383726439811G90CX13
0890383719888411F90CX19

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