← Back to catalogue

Strata™

FDA UDI

Class II (US FDA UDI)

by Medtronic PS Medical

Identity

Trade Name
Strata™ FDA UDI
Generic Name
Lumboperitoneal shunt spinal catheter FDA UDI
Device Name
CATHETER 44405 LUMBAR CLOSED TIP FDA UDI
Model / Reference
44405 FDA UDI
Description
CATHETER 44405 LUMBAR CLOSED TIP FDA UDI

Identifiers

Primary DI / UDI-DI
00643169975842 FDA UDI
510(k) Number
K123524 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Lumboperitoneal shunt spinal catheter 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

Dimensions & Sizes

Size
Lumen/Inner Diameter — 0.7 Millimeter FDA UDI

Category: Lumboperitoneal shunt spinal catheter

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

Similar devices

Also classified as Lumboperitoneal shunt spinal catheter.

Cleared under the same submission

K123524 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic PS Medical

Sources (1)

  • FDA UDI bc789e9e-d956-406d-a6b4-1fd170b28d96 36 fields · synced Jun 1, 2026