Olsen Medical 80301-

GUDID 00841785113352

OLSEN MEDICAL, LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

Primary Device ID	00841785113352
NIH Device Record Key	21000a91-b6de-493f-802d-8f51ac5dc999
Commercial Distribution Status	In Commercial Distribution
Brand Name	Olsen Medical
Version Model Number	80301-
Catalog Number	80301-
Company DUNS	079344210
Company Name	OLSEN MEDICAL, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841785113352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K130669

FDA Product Code

GEI	Electrosurgical, Cutting & Coagulation & Accessories