STAPES H'PC F/DIEGO (NO EEPROM) REFURBISHED

GUDID 00821925030848

Gyrus Acmi, Inc.

ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece ENT shaver system handpiece Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use

Primary Device ID	00821925030848
NIH Device Record Key	e726378f-3389-4a38-9934-17e8be4ac7af
Commercial Distribution Status	In Commercial Distribution
Brand Name	STAPES H'PC F/DIEGO (NO EEPROM) REFURBISHED
Version Model Number	70338032R
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	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	00821925030848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K992994

FDA Product Code

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