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Sutter

FDA UDI

Class II (US FDA UDI)

by Sutter Medizintechnik GmbH

Identity

Trade Name
Sutter FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Device Name
Bipolar electrode Single-Use Soft Palate incl. cable 3m for CURIS® FDA UDI
Model / Reference
704495 FDA UDI
Description
Bipolar electrode Single-Use Soft Palate incl. cable 3m for CURIS® FDA UDI

Identifiers

Catalog Number
704495 FDA UDI
Primary DI / UDI-DI
ESUM7044950 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

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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

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

Sutter by Sutter Medizintechnik GmbH — 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
Sutter Medizintechnik GmbH

Sources (1)

  • FDA UDI 57e824fc-cae6-4219-a9e8-3033bd7df848 35 fields · synced May 29, 2026