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Aesculap

FDA UDI

Class II (US FDA UDI)

by Aesculap, Inc.

Identity

Trade Name
AESCULAP FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Device Name
GOLDTIP IRRIG DISPO FCPS 215MM 0.5MM FDA UDI
Model / Reference
US410SU FDA UDI
Description
GOLDTIP IRRIG DISPO FCPS 215MM 0.5MM FDA UDI

Identifiers

Catalog Number
US410SU FDA UDI
Primary DI / UDI-DI
04046964583483 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

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

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aesculap, Inc.

Sources (1)

  • FDA UDI 6eb7b34a-e70d-4525-8dd8-425a8c62e975 35 fields · synced Jun 7, 2026