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XCOIL Encapsulator XE400

by Nexgen Medical Systems, 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 Number00855975007048 UDI-DI Date31 May 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  • Withdrawn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
XCOIL Encapsulator
Generic Name
Vascular guide-catheter, single-use
Model / Reference
XE400
Primary DI / UDI-DI
00855975007048
FDA Product Code
DYB
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1340
GUDID distribution status
Not in Commercial Distribution
Size
Length — 80 Centimeter

Other devices from Nexgen Medical Systems, Inc.

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