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Erbe

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 20132-217

by Erbe Elektromedizin GmbH

Identity

Trade Name
FiAPC®-Sonde m. Filter 2200 SC EUDAMED
ERBE FDA UDI
Generic Name
Inert gas-enhanced endoscopic electrosurgical electrode, single-use FDA UDI
Device Name
FiAPC probes, SU EUDAMED
FiAPC® probe w/ filter 2200 SC OD 2.3mm/6.9Fr; L 2.2m/7.2ft FDA UDI
Model / Reference
20132-217 EUDAMEDFDA UDI
Description
FiAPC® probe w/ filter 2200 SC OD 2.3mm/6.9Fr; L 2.2m/7.2ft FDA UDI

Identifiers

Catalog Number
20132-217 FDA UDI
Primary DI / UDI-DI
04050147013995 EUDAMEDFDA UDI
Basic UDI-DI
B-04050147013995 EUDAMED
510(k) Number
K060183 FDA UDI
FDA Product Code
GEI FDA UDI
EMDN Code
K02040199 ARGON GAS SURGERY INSTRUMENTS, SINGLE-USE- OTHER EUDAMED
GMDN Term
Inert gas-enhanced endoscopic electrosurgical electrode, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 2.200 Meter FDA UDI

Category: Inert gas-enhanced endoscopic electrosurgical electrode, single-use

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

Similar devices

Also classified as Inert gas-enhanced endoscopic electrosurgical electrode, single-use.

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Sources (2)

  • FDA UDI aeff4a6d-9f40-40b8-a96b-333c9faf84cc 38 fields · synced Jul 12, 2026
  • EUDAMED ac68433b-2113-4a50-a84f-6b8f85d73130 61 fields · synced Jul 12, 2026