USA Elite System™ Iglesias™ Working Element

GUDID 00821925008229

Gyrus Acmi, Inc.

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Primary Device ID	00821925008229
NIH Device Record Key	1e7f4fa6-8c3a-4047-bc21-67932df8e648
Commercial Distribution Status	In Commercial Distribution
Brand Name	USA Elite System™ Iglesias™ Working Element
Version Model Number	REXEIWE
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	00821925008229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K951972

FDA Product Code

FBO	CYSTOURETHROSCOPE