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X-Pac EI3861

by Expanding Innovations, Inc.

X-Pac EI3861 is a Class I device made by Expanding Innovations, Inc., listed in FDA GUDID since 24 Sep 2025 (UDI-DI 00810166520133), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810166520133 UDI-DI Date24 Sep 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
X-Pac
Generic name
Orthopaedic joint/limb rongeur
Model / reference
EI3861
Primary DI / UDI-DI
00810166520133
FDA product code
HTX
GMDN term
Orthopaedic joint/limb rongeur
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Expanding Innovations, Inc.

See all devices from Expanding Innovations, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)