GYRUS ACMI

GUDID 00821925038356

Ellik Tubing For Ellik/Toomey Adapters

Gyrus Acmi, Inc.

Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable Bladder evacuator, reusable

Primary Device ID	00821925038356
NIH Device Record Key	ed066f1f-11ae-4844-9b1c-7259ce9e05e2
Commercial Distribution Status	In Commercial Distribution
Brand Name	GYRUS ACMI
Version Model Number	ET
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	00821925003248 [Package] Package: [6 Units] In Commercial Distribution
GS1	00821925038356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K890328

FDA Product Code

FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL