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ClearPoint CP-SFL-01

by Clearpoint Neuro, Inc.

ClearPoint CP-SFL-01 is a Class I device made by Clearpoint Neuro, Inc., listed in FDA GUDID since 13 Feb 2026 (UDI-DI 00850047354686), 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 Number00850047354686 UDI-DI Date13 Feb 2026ListedStatusListed 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  • Withdrawn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
ClearPoint
Generic name
Intracranial catheter holder
Model / Ref / Catalog
CP-SFL-01
Primary DI / UDI-DI
00850047354686
FDA product code
MDM
GMDN term
Intracranial catheter holder
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Similar devices

Other devices filed under FDA product code MDM (Instrument, Manual, Surgical, General Use).

Other devices from Clearpoint Neuro, Inc.

See all devices from Clearpoint Neuro, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)