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Focalist Universal Short Instrument Guide Kit K002-01

by Mendaera, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00850062065055 UDI-DI Date29 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Focalist Universal Short Instrument Guide Kit
Generic Name
Needle guide, single-use
Model / Reference
K002-01
Primary DI / UDI-DI
00850062065055
510(k) Number
FDA Product Code
ITX
GMDN Term
Needle guide, single-use
Device Class
Class II
Regulation Number
892.1570
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 165 Millimeter

Related devices

Cleared under the same submission (K250524)

Show all (10)

Other devices from Mendaera, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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