MTR-AC-04

GUDID 08800016904253

CLASSYS Inc.

Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID08800016904253
NIH Device Record Keyb0fb4dad-6446-4384-b23d-b85ee97d1541
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTR-AC-04
Version Model NumberMTR-AC-04
Company DUNS689842183
Company NameCLASSYS Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS108800016904253 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-10
Device Publish Date2025-07-02

Devices Manufactured by CLASSYS Inc.

08800016903140 - Max-252025-07-10
08800016903171 - Max-M252025-07-10
08800016903423 - Max-25C2025-07-10
08800016903447 - Max-64C2025-07-10
08800016903454 - Max-M25C2025-07-10
08800016904246 - MTR-AC-012025-07-10
08800016904253 - MTR-AC-042025-07-10
08800016904253 - MTR-AC-042025-07-10
08800016904291 - MTR-AC-27G2025-07-10

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