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NA Stylet

by C R I 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00852073002562 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1481-2015 FDA Class II initiated 7 Apr 2015 on shared 510(k) K032835

    HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Catheter stylet
Model / Ref / Catalog
Stylet, TMI1156
Primary DI / UDI-DI
00852073002562
510(k) Number
FDA Product Code
LKF
GMDN Term
Catheter stylet
Device Class
Class II
Regulation Number
884.4530
GUDID distribution status
In Commercial Distribution

Related devices

Category: Catheter stylet

Cleared under the same submission (K032835)

Show all (12)

Other devices from C R I

See all devices from C R I →

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