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Tissu-Trans MEGA 1500

by Shippert Medical Technologies Corp.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

8 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 Number00893398002271 UDI-DI Date10 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

8 recalls · FDA

  • 5 recalls, same reason

    • Completed Z-1335-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1330-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1336-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1331-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1332-2019 FDA Class II initiated 2 Feb 2018

    The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.

  • 2 recalls, same reason

    • Completed Z-1334-2019 FDA Class II initiated 2 Feb 2018
    • Completed Z-1333-2019 FDA Class II initiated 2 Feb 2018
    • Terminated Z-0170-2018 FDA Class II initiated 20 Oct 2017

    Potential breach of sterility of the packaging.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Tissu-Trans MEGA
Generic Name
Surgical suction system collection container, single-use
Model / Ref / Catalog
Tissu-Trans MEGA 1500, 3-TT-MEGA 1500
Primary DI / UDI-DI
00893398002271
510(k) Number
FDA Product Code
MUU
GMDN Term
Surgical suction system collection container, single-use
Device Class
Class II
Regulation Number
878.5040
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K092482)

Show all (12)

Other devices from Shippert Medical Technologies Corp.

See all devices from Shippert Medical Technologies Corp. →

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