DISPOSABLE BIPOLAR CORD SINGLE USE SUPER FLEXIBLE LENGTH 12.0' DISTRI

GUDID 00821925017832

Gyrus Acmi, Inc.

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Primary Device ID	00821925017832
NIH Device Record Key	410472c7-f611-448e-8449-6f74d4493aae
Commercial Distribution Status	In Commercial Distribution
Brand Name	DISPOSABLE BIPOLAR CORD SINGLE USE SUPER FLEXIBLE LENGTH 12.0' DISTRI
Version Model Number	131510
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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	00821925017832 [Package] Contains: 00821925037687 Package: [6 Units] In Commercial Distribution
GS1	00821925037687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K831236

FDA Product Code

GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-10-07