REUSABLE BIPOLAR CORD LENGTH 12.0'

GUDID 00821925018938

Gyrus Acmi, Inc.

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Primary Device ID	00821925018938
NIH Device Record Key	f81df61a-000f-40a2-917f-3e019e7d0dd9
Commercial Distribution Status	In Commercial Distribution
Brand Name	REUSABLE BIPOLAR CORD LENGTH 12.0'
Version Model Number	131509
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	false
OTC Over-The-Counter	true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925018938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K831236

FDA Product Code

GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES