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Strata®

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
STRATA® FDA UDI
Generic Name
Cerebrospinal fluid shunt valve programmer FDA UDI
Device Name
SET ADJUST 45905 STRATAMR MAGNET FDA UDI
Model / Reference
45905 FDA UDI
Description
SET ADJUST 45905 STRATAMR MAGNET FDA UDI

Identifiers

Primary DI / UDI-DI
00643169692886 FDA UDI
510(k) Number
K152700 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Cerebrospinal fluid shunt valve programmer 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Category: Cerebrospinal fluid shunt valve programmer

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

Similar devices

Also classified as Cerebrospinal fluid shunt valve programmer.

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 2a425935-d22c-46f5-8ca8-d9df3787c3a6 35 fields · synced May 31, 2026