USA Elite System™ Iglesias™ Working Element

GUDID 00821925001916

EIWE MONO Iglesias Working Element

Gyrus Acmi, Inc.

Resectoscope Resectoscope Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide Rigid endoscope working guide

Primary Device ID	00821925001916
NIH Device Record Key	31ee7503-63ff-4a91-9a63-52b69e04e54b
Commercial Distribution Status	In Commercial Distribution
Brand Name	USA Elite System™ Iglesias™ Working Element
Version Model Number	EIWE
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	00821925001916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K951972

FDA Product Code

FBO	CYSTOURETHROSCOPE