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2.7x350mm Transsacral Beveled Tip Wire THD 2004-0142

by OsteoCentric Technologies, Inc GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810074305044 UDI-DIDate21 Oct 2025ListedStatusListed GUDID: 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  • Withdrawn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
2.7x350mm Transsacral Beveled Tip Wire THD
Generic Name
Orthopaedic guidewire, single-use
Model / Ref / Catalog
2004-0142
Primary DI / UDI-DI
00810074305044
510(k) Number
FDA Product Code
FZX
GMDN Term
Orthopaedic guidewire, single-use
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 2.7 Millimeter
Length — 350 Millimeter

Related devices

Cleared under the same submission (K242691)

Show all (12)

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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