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Parkell

FDA UDI

Class II (US FDA UDI)

by Parkell, Inc.

Identity

Trade Name
Parkell FDA UDI
Generic Name
Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
Device Name
AP-1 1/2 Electrosurge Electrode FDA UDI
Model / Reference
AP-1 1/2 FDA UDI
Description
AP-1 1/2 Electrosurge Electrode FDA UDI

Identifiers

Catalog Number
S397-AP1.5 FDA UDI
Primary DI / UDI-DI
00810000526703 FDA UDI
FDA Product Code
EKZ FDA UDI
GMDN Term
Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4920 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery electrosurgical electrode, monopolar, reusable

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

Similar devices

Also classified as Open-surgery electrosurgical electrode, monopolar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Parkell, Inc.

Sources (1)

  • FDA UDI efd4102b-7070-4eb8-8710-10e0595e2c56 35 fields · synced Jun 8, 2026