DIEGO POWER DISSECTOR CONSOLE

GUDID 00821925011441

Gyrus Acmi, Inc.

ENT shaver system ENT shaver system Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable

Primary Device ID	00821925011441
NIH Device Record Key	9a38195d-bb9b-4da0-a4f6-896c96dc5ab8
Commercial Distribution Status	In Commercial Distribution
Brand Name	DIEGO POWER DISSECTOR CONSOLE
Version Model Number	70338000
Company DUNS	007198742
Company Name	Gyrus Acmi, Inc.
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	false
Serial Number	true
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	00821925011441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K020594

FDA Product Code

ERL	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE