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Sutter

FDA UDI

Class II (US FDA UDI)

by Sutter Medizintechnik GmbH

Identity

Trade Name
Sutter FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
Calvian endo-pen®, straight angled, US 35°, WL 18cm, tip 1.0mm, duckbill FDA UDI
Model / Reference
700951S FDA UDI
Description
Calvian endo-pen®, straight angled, US 35°, WL 18cm, tip 1.0mm, duckbill FDA UDI

Identifiers

Catalog Number
700951S FDA UDI
Primary DI / UDI-DI
ESUM700951S0 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, bipolar, 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable

Sutter by Sutter Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical handpiece/electrode, bipolar, reusable.

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 569c7d5c-b330-4bf6-a2c3-d7c0b944ad2e 35 fields · synced May 30, 2026