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Orantech

FDA UDI

Class II (US FDA UDI)

by Orantech Inc.

Identity

Trade Name
Orantech FDA UDI
Generic Name
Multi-purpose invasive/noninvasive electrode kit FDA UDI
Device Name
Limb Clamp Electrode(Color:red / black / green / yellow), Pediatric, IEC, 4pcs/Set FDA UDI
Model / Reference
EKA-LCP-I FDA UDI
Description
Limb Clamp Electrode(Color:red / black / green / yellow), Pediatric, IEC, 4pcs/Set FDA UDI

Identifiers

Primary DI / UDI-DI
06941691946144 FDA UDI
FDA Product Code
DRX FDA UDI
GMDN Term
Multi-purpose invasive/noninvasive electrode kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2360 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-purpose invasive/noninvasive electrode kit

Orantech by Orantech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose invasive/noninvasive electrode kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orantech Inc.

Sources (1)

  • FDA UDI a1ceede9-d427-4f28-8f55-f9b0c4552c51 33 fields · synced May 30, 2026