MT ONE DIAMOND

GUDID 08057622080042

M & T SRL

Dermatological diode laser system
Primary Device ID08057622080042
NIH Device Record Key77ff2331-137a-4a91-a0e6-83ed5d83f9a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameMT ONE DIAMOND
Version Model NumberMT ONE DIAMOND
Company DUNS441794981
Company NameM & T SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108057622080042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-23
Device Publish Date2025-04-15

Devices Manufactured by M & T SRL

08057622080004 - MTONE EVO2025-04-23
08057622080011 - MTONE EVO2025-04-23
08057622080028 - MT ONE2025-04-23
08057622080035 - MT ONE2025-04-23
08057622080042 - MT ONE DIAMOND2025-04-23
08057622080042 - MT ONE DIAMOND2025-04-23

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