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Conmed

FDA UDI

Class II (US FDA UDI)

by Conmed Corporation

Identity

Trade Name
CONMED FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Device Name
CABLE:SAFETY;3LD FDA UDI
Model / Reference
R396II FDA UDI
Description
CABLE:SAFETY;3LD FDA UDI

Identifiers

Catalog Number
R396II FDA UDI
Primary DI / UDI-DI
30653405048149 FDA UDI
510(k) Number
K912415 FDA UDI
FDA Product Code
BZQ FDA UDI
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Category: Electrocardiographic lead set, reusable

Conmed by Conmed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead set, reusable.

Cleared under the same submission

K912415 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conmed Corporation

Sources (1)

  • FDA UDI d20076c5-a099-4203-a3cd-65d332c30a32 37 fields · synced May 30, 2026