DIEGO HANDPIECE CLEANING KIT NONSTERILE .475"(12.07mm) DIA and .437"

GUDID 00821925026131

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 Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable Electrosurgical handpiece, reusable

Primary Device ID	00821925026131
NIH Device Record Key	b9eb156a-a4ec-4951-88b9-a7638491a6c4
Commercial Distribution Status	In Commercial Distribution
Brand Name	DIEGO HANDPIECE CLEANING KIT NONSTERILE .475"(12.07mm) DIA and .437"
Version Model Number	70338009
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	true
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	00821925026131 [Package] Contains: 00821925034488 Package: [6 Units] In Commercial Distribution
GS1	00821925034488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K020594

FDA Product Code

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