Footswitch APYX-1253B

GUDID 00607151050191

Footswitch Monopolar

APYX MEDICAL CORPORATION

Electrosurgical system
Primary Device ID00607151050191
NIH Device Record Key48bde69d-b9ef-497f-9995-4fe59f1e54c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameFootswitch
Version Model NumberAPYX-1253B
Catalog NumberAPYX-1253B
Company DUNS101223287
Company NameAPYX MEDICAL CORPORATION
Device Count1
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 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
GS100607151050191 [Primary]

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 Date2020-03-31
Device Publish Date2020-03-23

On-Brand Devices [Footswitch]

00607151050207Footswitch Bipolar
00607151050191Footswitch Monopolar

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