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DF4 Helix Locking Tool A002HELX

by CenterPoint Systems LLC

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

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 Number00810024671724 UDI-DI Date3 Dec 2025ListedStatusListed GUDID: 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  • Withdrawn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
DF4 Helix Locking Tool
Generic Name
Torque manipulation device
Model / Reference
A002HELX
Primary DI / UDI-DI
00810024671724
FDA Product Code
DWS
GMDN Term
Torque manipulation device
Device Class
Class I
Regulation Number
870.4500
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from CenterPoint Systems LLC

See all devices from CenterPoint Systems LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (8)

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