Thermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10

GUDID 05032384550784

OXOID LIMITED

Antibacterial susceptibility testing disc IVD
Primary Device ID05032384550784
NIH Device Record Keycd11f835-ef83-4809-9c3a-90e03fecd899
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermo Scientific Oxoid Gepotidacin Disc (10 ug) GEP10
Version Model NumberCT1975B
Company DUNS365355452
Company NameOXOID LIMITED
Device Count5
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 Datefalse
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
GS105032384550784 [Primary]
GS105032384591817 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JTNSusceptibility Test Discs, Antimicrobial

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-29
Device Publish Date2026-01-21

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