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Rezūm Accessory Kit D2202

by Nxthera, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number00855357006034 UDI-DI Date17 Jul 2017ListedStatusListed GUDID: not 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  • Withdrawn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
Rezūm Accessory Kit
Generic Name
Irrigation syringe
Model / Reference
D2202
Primary DI / UDI-DI
00855357006034
FDA Product Code
GEI
GMDN Term
Irrigation syringe
Device Class
Class II
Regulation Number
878.4400
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe

Other devices from Nxthera, Inc.

  • rezum D2201

    Class II

  • Rezum System

    Class II

  • Rezum System

    Class II

  • Rezum System

    Class II

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No