TUBESET WITH FILTER FOR SUCTION MODULE DIEGO ELITE

GUDID 00821925027831

Gyrus Acmi, Inc.

ENT shaver system

Primary Device ID	00821925027831
NIH Device Record Key	ab2fbb84-4c06-4be4-8221-862984d39ede
Commercial Distribution Status	In Commercial Distribution
Brand Name	TUBESET WITH FILTER FOR SUCTION MODULE DIEGO ELITE
Version Model Number	TS102SF
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

Operating and Storage Conditions

Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between 25 Degrees Celsius and 60 Degrees Celsius
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925027831 [Package] Contains: 00821925040670 Package: [5 Units] In Commercial Distribution
GS1	00821925040670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123429

FDA Product Code

GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES