JRF-Pad-01

GUDID 08800020102836

JRF-Pad-01

Jeisys Medical Inc.

Electrosurgical system
Primary Device ID08800020102836
NIH Device Record Key90599b90-fe80-490a-9712-25936bbf758b
Commercial Distribution StatusIn Commercial Distribution
Brand NameJRF-Pad-01
Version Model NumberJRF-Pad-01
Company DUNS690275362
Company NameJeisys Medical Inc.
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 Usefalse
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
GS108800020102836 [Primary]
GS108800020106810 [Unit of Use]

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 Date2025-12-18
Device Publish Date2025-12-10

Devices Manufactured by Jeisys Medical Inc.

08800020102836 - JRF-Pad-012025-12-18JRF-Pad-01
08800020102836 - JRF-Pad-012025-12-18 JRF-Pad-01
08800020106759 - Jeisys Medical Inc.2025-09-05 DENSITY Noir Main body
08800020106407 - Jeisys Medical Inc.2025-09-02 ALPHA Tip
18800020105506 - POTENZA Tip2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-25 Tip)
18800020105612 - POTENZA Tip2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-16 Tip)
18800020105629 - POTENZA Tip2025-05-27 POTENZA Tip (Sterile micro needle electrode CP-49 Tip)
18800020106299 - POTENZA Tip2025-05-27 POTENZA Tip (DDR Tip)
08800020106308 - POTENZA Tip2025-05-27 POTENZA Tip (SFA Tip)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.