USA Elite System™ Cystourethroscope Visual Obturator 21 Fr, (7 mm) C

GUDID 00821925003323

E161 Cystourethroscope Visual OBT 21FR

Gyrus Acmi, Inc.

Rigid cystourethroscope Rigid cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope Rigid optical cystourethroscope

Primary Device ID	00821925003323
NIH Device Record Key	1d1d087f-33fe-47ab-a703-6cc796d98577
Commercial Distribution Status	In Commercial Distribution
Brand Name	USA Elite System™ Cystourethroscope Visual Obturator 21 Fr, (7 mm) C
Version Model Number	E161
Company DUNS	007198742
Company Name	Gyrus Acmi, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	00821925003323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K890328

FDA Product Code

FEC	OBTURATOR, FOR ENDOSCOPE