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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
FlexTip Bipolar electrodes single-use WL: 35cm, CURIS plug FDA UDI
Model / Reference
AR-S9805-0035 FDA UDI
Description
FlexTip Bipolar electrodes single-use WL: 35cm, CURIS plug FDA UDI

Identifiers

Catalog Number
AR-S9805-0035 FDA UDI
Primary DI / UDI-DI
ESUMARS980500350 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 ec917bf8-d6e3-44f3-889e-0730222700d6 35 fields · synced Jun 1, 2026