C1® DEPTH LIMITER 022012

GUDID 00850200006896

C1® DEPTH LIMITER

LSI Solutions, Inc.

Suturing unit depth limiter Suturing unit depth limiter Suturing unit depth limiter Suturing unit depth limiter Suturing unit depth limiter Suturing unit depth limiter Suturing unit depth limiter Suturing unit depth limiter

Primary Device ID	00850200006896
NIH Device Record Key	19027be8-4fba-4870-bd0c-03fda9e3abac
Commercial Distribution Status	In Commercial Distribution
Brand Name	C1® DEPTH LIMITER
Version Model Number	022012
Catalog Number	022012
Company DUNS	603420183
Company Name	LSI Solutions, Inc.
Device Count	1
DM Exempt	true
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	true
Manufacturing Date	true
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

Customer Support Contacts

Phone	+1(866)575-3493
Email	regulatorydpt@lsisolutions.com
Phone	+1(866)575-3493
Email	regulatorydpt@lsisolutions.com
Phone	+1(866)575-3493
Email	regulatorydpt@lsisolutions.com
Phone	+1(866)575-3493
Email	regulatorydpt@lsisolutions.com
Phone	+1(866)575-3493
Email	regulatorydpt@lsisolutions.com
Phone	+1(866)575-3493
Email	regulatorydpt@lsisolutions.com
Phone	+1(866)575-3493
Email	regulatorydpt@lsisolutions.com
Phone	+1(866)575-3493
Email	regulatorydpt@lsisolutions.com

Device Dimensions

Width	11 Millimeter
Width	11 Millimeter
Width	11 Millimeter
Width	11 Millimeter
Width	11 Millimeter
Width	11 Millimeter
Width	11 Millimeter
Width	11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100593

FDA Product Code

HCF	INSTRUMENT, LIGATURE PASSING AND KNOT TYING