Strata™

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name: Strata™ FDA UDI
Generic Name: Lumboperitoneal shunt FDA UDI
Device Name: SHUNT 44420 STRATA KIT NSC LP FDA UDI
Model / Reference: 44420 FDA UDI
Description: SHUNT 44420 STRATA KIT NSC LP FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169975866 FDA UDI
510(k) Number: K123524 FDA UDI
FDA Product Code: JXG FDA UDI
GMDN Term: Lumboperitoneal shunt 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 120.0 Centimeter FDA UDI

Category: Lumboperitoneal shunt

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

Similar devices

Also classified as Lumboperitoneal shunt.

GAV 2.0 — AESCULAP, INC. · Class II
Integra Spetzler™ Lumbar Peritoneal Shunt System — Integra Lifesciences Corp. · Class II
SHUNTASSISTANT 2.0 — AESCULAP, INC. · Class II
Natus® — Natus Medical Incorporated · Class II
SHUNTASSISTANT 2.0 — AESCULAP, INC. · Class II
CODMAN® — Integra LifeSciences Production Corporation · Class II
CODMAN® HOLTER® — Integra LifeSciences Production Corporation · Class II
GAV 2.0 — AESCULAP, INC. · Class II

Cleared under the same submission

K123524 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic PS Medical

Sources (1)

FDA UDI eacc43cd-5f91-440e-a257-bd7fb4225509 36 fields · synced May 31, 2026