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Sutter 700955S

by Sutter Medizintechnik GmbH

Sutter 700955S is a Class II device made by Sutter Medizintechnik GmbH, listed in FDA GUDID since 21 Jun 2018 (UDI-DI ESUM700955S0), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberESUM700955S0 UDI-DI Date21 Jun 2018ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Sutter
Generic name
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Model / Ref / Catalog
700955S
Description
Calvian endo-pen®, axial handle, US 45°, WL 10cm, forceps style tip 2,5mm
Primary DI / UDI-DI
ESUM700955S0
FDA product code
GEI
GMDN term
Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)