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Vagiwell 0 size 10-11/112mm

by KESSEL medintim GmbH

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04013273000970 UDI-DI Date30 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Vaginal dilator
Model / Ref / Catalog
Vagiwell 0
Description
Device to dilatate the vagina in case of Radiotherapy, Chemotherapy, after vaginal surgery, vaginismus, narrowness of the vagina, lichen sclerosus
Primary DI / UDI-DI
04013273000970
FDA Product Code
HDQ
GMDN Term
Vaginal dilator
Device Class
Class I
Regulation Number
884.4530
GUDID distribution status
In Commercial Distribution

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See all devices from KESSEL medintim GmbH →

Properties

  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No