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StrataMR

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
StrataMR FDA UDI
Generic Name
Cerebrospinal fluid shunt valve FDA UDI
Device Name
ASSY 46965 FP SHUNT STRATAMR REGULAR FDA UDI
Model / Reference
46965 FDA UDI
Description
ASSY 46965 FP SHUNT STRATAMR REGULAR FDA UDI

Identifiers

Primary DI / UDI-DI
00643169593435 FDA UDI
510(k) Number
K152700 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Cerebrospinal fluid shunt valve FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 120.0 Centimeter FDA UDI

Category: Cerebrospinal fluid shunt valve

A comprehensive medical device that regulates intracranial pressure (ICP) in patients with hydrocephalus or other conditions. It consists of a mechanical valve with catheter connections made from synthetic polymer and/or metallic materials, which opens at a pre-set pressure and may be adjusted using a dedicated programmer.

Similar devices

Also classified as Cerebrospinal fluid shunt valve.

Cleared under the same submission

K152700 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 b7496637-f7dc-4986-9b74-f019ad394936 36 fields · synced Jun 27, 2026