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Erbe

FDA UDI

Class II (US FDA UDI)

by Erbe Elektromedizin GmbH

Identity

Trade Name
ERBE FDA UDI
Generic Name
Inert gas-enhanced open-surgery electrosurgical electrode, reusable FDA UDI
Device Name
APC-applicator 300 A, rigid, OD: 2.3 mm, L: 300 mm FDA UDI
Model / Reference
20132-113 FDA UDI
Description
APC-applicator 300 A, rigid, OD: 2.3 mm, L: 300 mm FDA UDI

Identifiers

Catalog Number
20132-113 FDA UDI
Primary DI / UDI-DI
04050147000902 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Inert gas-enhanced open-surgery electrosurgical electrode, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 300.000 Millimeter FDA UDI

Category: Inert gas-enhanced open-surgery electrosurgical electrode, reusable

Erbe by Erbe Elektromedizin GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inert gas-enhanced open-surgery electrosurgical electrode, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Erbe Elektromedizin GmbH

Sources (1)

  • FDA UDI e9be535e-35bf-40d8-803b-79111aa59fca 37 fields · synced Jun 6, 2026