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Flex Small 4 MR coil 3T

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare

Identity

Trade Name
Flex Small 4 MR coil 3T FDA UDI
Generic Name
PET/MRI system FDA UDI
Device Name
MRI Coil FDA UDI
Model / Reference
10835327 FDA UDI
Description
MRI Coil FDA UDI

Identifiers

Primary DI / UDI-DI
04056869015422 FDA UDI
FDA Product Code
MOS FDA UDI
OUO FDA UDI
LNH FDA UDI
LNI FDA UDI
GMDN Term
PET/MRI system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
892.1200 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Full-body MRI system, superconducting magnetPET/MRI system

Flex Small 4 MR coil 3T by Siemens Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as PET/MRI system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare

Sources (1)

  • FDA UDI 580d6eb8-1d65-4b73-9cd2-5d0ebd4f33e4 34 fields · synced May 30, 2026