Innervision

GUDID 00613994908483

KIT 2120-125 INNER/ENDO SHUNT PLCMT REG

MEDTRONIC PS MEDICAL, INC.

Neuroscopic shunt placement kit

• Primary Device ID: 00613994908483
• NIH Device Record Key: 6978b566-d3a1-41de-af44-2f3658e5aafb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Innervision
• Version Model Number: 2120-125
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter
• Length: 15.5 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Special Storage Condition, Specify: Between 0 and 0 *Fragile

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994908483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940096

FDA Product Code

• GWG: ENDOSCOPE, NEUROLOGICAL

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: 2015-07-21

On-Brand Devices [Innervision]

• 00613994908483: KIT 2120-125 INNER/ENDO SHUNT PLCMT REG
• 00613994908254: KIT 27588 INRVSN ENDO SHUNT PLACEMNT
• 00613994966018: CATH 27065 D VENT SNAP ENDO 7CM
• 00613994965998: CATH 27065 F VENT SNAP ENDO 9CM
• 00613994965981: CATH 27065 G VENT SNAP ENDO 10CM
• 00613994965974: CATH 27065 H VENT SNAP ENDO 11CM
• 00613994965950: SHUNT 27065 K INNERV SNAP W/VCATH 5.5CM
• 00613994965943: SHUNT 27065 L INNERV SNAP W/VCATH 6.5CM
• 00613994965738: V-CATH 27298 INNERVISION W/ SNAP BASE
• 00613994965691: CATH 27600 VENT INNERVISION SLOTTED 15CM
• 00643169499249: CATHETER 27065 A VENT SNAP ENDO 4CM
• 00643169498150: CATHETER 27165 VENT INNERVISION 1.5X2.8
• 00643169498136: V-CATH 27298 INNERVISION W/ SNAP BASE
• 00643169498082: CATH 27623 INNERV15CM XTRA HOLES 2CM
• 00643169496835: CATH 27781 INNERV 3 SETS FLOW HLS 23CM
• 00643169483897: CATHETER 27065 B VENT SNAP ENDO 5CM
• 00643169483880: CATHETER 27065 C VENT SNAP ENDO 6CM
• 00643169483873: CATH 27065 D VENT SNAP ENDO 7CM
• 00643169483866: CATH 27065 EVENT SNAP ENDO 8CM
• 00643169483859: CATH 27065 F VENT SNAP ENDO 9CM
• 00643169483842: CATH 27065 G VENT SNAP ENDO 10CM
• 00643169483835: CATH 27065 H VENT SNAP ENDO 11CM
• 00643169483828: SHUNT 27065 K INNERV SNAP W/VCATH 5.5CM
• 00643169483811: SHUNT 27065 L INNERV SNAP W/VCATH 6.5CM
• 00643169472723: CATH 27240 INNERVISION 15CM
• 00681490526852: KIT 27628 CSF-VENT RES BH VCATH 15CM
• 00721902992247: CATH 27781 INNERV 3 SETS FLOW HLS 23CM
• 00763000030926: CATHETER 27065 A VENT SNAP ENDO 4CM
• 00763000030742: CATHETER 27165 VENT INNERVISION 1.5X2.8
• 00763000029920: CATHETER 27065 B VENT SNAP ENDO 5CM
• 00763000029913: CATHETER 27065 C VENT SNAP ENDO 6CM
• 00763000029906: CATH 27065 D VENT SNAP ENDO 7CM
• 00763000029890: CATH 27065 EVENT SNAP ENDO 8CM
• 00763000029883: CATH 27065 F VENT SNAP ENDO 9CM
• 00763000029876: CATH 27065 G VENT SNAP ENDO 10CM
• 00763000029869: CATH 27065 H VENT SNAP ENDO 11CM
• 00763000028848: CATH 27240 INNERVISION 15CM
• 00763000027315: CATH 27600 VENT INNERVISION SLOTTED 15CM