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Innervision

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
Innervision FDA UDI
Generic Name
Neuroscopic shunt placement kit FDA UDI
Device Name
KIT 27588 INRVSN ENDO SHUNT PLACEMNT FDA UDI
Model / Reference
27588 FDA UDI
Description
KIT 27588 INRVSN ENDO SHUNT PLACEMNT FDA UDI

Identifiers

Primary DI / UDI-DI
00613994908254 FDA UDI
510(k) Number
K063836 FDA UDI
FDA Product Code
JXG FDA UDI
HCA FDA UDI
GMDN Term
Neuroscopic shunt placement kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
882.4100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.1 Millimeter FDA UDI
Angle — 0.0 degree FDA UDI
Length — 15.5 Centimeter FDA UDI

Category: Neuroscopic shunt placement kit

Innervision by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neuroscopic shunt placement kit.

Cleared under the same submission

K063836 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic PS Medical

Sources (1)

  • FDA UDI 66b3fdf6-24b7-4bff-b4b8-1b65e8ffd41b 37 fields · synced May 31, 2026