Grounding Plate

GUDID 18800016902751

CLASSYS Inc.

Electrosurgical return electrode, single-use
Primary Device ID18800016902751
NIH Device Record Key17a78891-2990-4a33-b441-57b2c74b9852
Commercial Distribution StatusIn Commercial Distribution
Brand NameGrounding Plate
Version Model Number6510-00025-001
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 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
GS108800016902754 [Primary]
GS118800016902751 [Package]
Contains: 08800016902754
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-12
Device Publish Date2024-08-03

Devices Manufactured by CLASSYS Inc.

08800016903287 - Secret RF Set Package2024-11-04
08800016902709 - VOLNEWMER S tip2024-08-12
08800016902716 - VOLNEWMER V tip2024-08-12
08800016902723 - VOLNEWMER F tip2024-08-12
08800016902730 - VOLNEWMER I tip2024-08-12
18800016902751 - Grounding Plate2024-08-12
18800016902751 - Grounding Plate2024-08-12
18800016902799 - Coupling Gel2024-08-12
08800016902945 - VOLNEWMER2024-08-12

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