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Snowden-Pencer 885059

by STERIS Deutschland GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

15 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00724995268398 UDI-DI Date25 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

15 recalls · 15 ongoing · FDA

  • 15 recalls, same reason

    • Ongoing Z-2427-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2429-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2428-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2415-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2422-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2425-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2426-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2419-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2420-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2418-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2424-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2423-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2421-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2416-2023 FDA Class II initiated 13 Jul 2023
    • Ongoing Z-2417-2023 FDA Class II initiated 13 Jul 2023

    Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Snowden-Pencer
Generic Name
ENT elevator
Model / Ref / Catalog
885059
Primary DI / UDI-DI
00724995268398
510(k) Number
FDA Product Code
GCJ
GMDN Term
ENT elevator
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K930667)

Show all (12)

Other devices from STERIS Deutschland GmbH

See all devices from STERIS Deutschland GmbH →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Manufacturing Date: No