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Nella Comfort Kit Curves Retail NEXTVSCK01

by Ceek Women's Health

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860000270489 UDI-DI Date15 Apr 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  • Withdrawn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

Trade Name
Nella Comfort Kit Curves Retail
Generic Name
Vaginal speculum, single-use
Model / Reference
NEXTVSCK01
Primary DI / UDI-DI
00860000270489
FDA Product Code
HIB
GMDN Term
Vaginal speculum, single-use
Device Class
Class II
Regulation Number
884.4530
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Patient Comfort Kit

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See all devices from Ceek Women's Health →

Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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