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StabiliT MX Fracture Kit MX-1100S-01

by Dfine, Inc. GUDID 2 variants

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850696006608 UDI-DIDate6 Jul 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
StabiliT MX Fracture Kit
Generic Name
Orthopaedic cement, non-antimicrobial
Model / Ref / Catalog
MX-1100S-01, MX-1100S
Primary DI / UDI-DI
00850696006608
FDA Product Code
NDN
GMDN Term
Orthopaedic cement, non-antimicrobial
Device Class
Class II
Regulation Number
888.3027
GUDID distribution status
Not in Commercial Distribution

Other devices from Dfine, Inc.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

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