Si-2 106119

GUDID 04035479000455

Implantable-device lubricant

Primary Device ID	04035479000455
NIH Device Record Key	f7fa6bea-ddbc-4676-8c90-a59e875ffe6a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Si-2
Version Model Number	106119
Catalog Number	106119
Company DUNS	315620229
Company Name	BIOTRONIK SE & Co. KG
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
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Temperature	Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	04035479000455 [Package] Contains: 04035479145262 Package: case [5 Units] In Commercial Distribution
GS1	04035479145262 [Primary]

DTB	permanent pacemaker Electrode

Steralize Prior To Use	false
Device Is Sterile	true