Innervision, BioGlide®

GUDID 00613994908476

KIT 2120-925 INNER/ENDO SHUNT PLCMT BIO

MEDTRONIC PS MEDICAL, INC.

Neuroscopic shunt placement kit
Primary Device ID00613994908476
NIH Device Record Key83bac517-defe-47a2-ab97-c7de97b5384d
Commercial Distribution StatusIn Commercial Distribution
Brand NameInnervision, BioGlide®
Version Model Number2120-925
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter1.1 Millimeter
Outer Diameter1.1 Millimeter
Outer Diameter1.1 Millimeter
Outer Diameter1.1 Millimeter
Outer Diameter1.1 Millimeter
Outer Diameter1.1 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994908476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGENDOSCOPE, NEUROLOGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-21

On-Brand Devices [Innervision, BioGlide®]

00613994908476KIT 2120-925 INNER/ENDO SHUNT PLCMT BIO
00643169472860CATH 99102 INNERVISION BIOGLIDE
00763000028961CATH 99102 INNERVISION BIOGLIDE

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