MEDRAD® 1.5T eCoil Interface Device (for Siemens)

FDA UDI

Class II (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name: MEDRAD® 1.5T eCoil Interface Device (for Siemens) FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: "ENDO INTERFACE DEVICE SIEMENS 1.5T SYM (60727854)" FDA UDI
Model / Reference: FID SYM FRU FDA UDI
Description: "ENDO INTERFACE DEVICE SIEMENS 1.5T SYM (60727854)" FDA UDI

Identifiers

Catalog Number: FID SYM FRU FDA UDI
Primary DI / UDI-DI: 00616258009049 FDA UDI
510(k) Number: K971380 FDA UDI
FDA Product Code: LNH FDA UDI
GMDN Term: MRI system coil, radio-frequency FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: MRI system coil, radio-frequency

MEDRAD® 1.5T eCoil Interface Device (for Siemens) by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K971380 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: Bayer Medical Care Inc.

Sources (1)

FDA UDI bc0b651e-c789-4492-96e1-bbb7d06a45f7 36 fields · synced Jun 9, 2026