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MEDALink

FDA UDI

Class II (US FDA UDI)

by Rising Eagle Medical

Identity

Trade Name
MEDALink FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Device Name
3 Lead, Pinch, Reusable, SL & Philips Compatible, 50in, ECG Leadwire, (1EA) FDA UDI
Model / Reference
M-PS-3PR-050 FDA UDI
Description
3 Lead, Pinch, Reusable, SL & Philips Compatible, 50in, ECG Leadwire, (1EA) FDA UDI

Identifiers

Catalog Number
M-PS-3PR-050 FDA UDI
Primary DI / UDI-DI
G096MPS3PR0500 FDA UDI
FDA Product Code
IKD FDA UDI
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1175 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic lead set, reusable

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Similar devices

Also classified as Electrocardiographic lead set, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rising Eagle Medical

Sources (1)

  • FDA UDI e92f34b1-9739-4975-85a6-a41d321ea757 34 fields · synced Jul 24, 2026