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MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube SSS-LP-60-T

by Bayer Medical Care Inc. 9 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

6 closed

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 Number00616258007151 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · FDA

    • Terminated Z-0745-2019 FDA Class II initiated 14 Dec 2018

    If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

    • Terminated Z-0147-2012 FDA Unclassified (pre-2012) initiated 24 Oct 2011

    Packaging may exhibit open seals - sterility compromised

    • Terminated Z-1954-2010 FDA Unclassified (pre-2012) initiated 24 May 2010

    Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury.

    • Terminated Z-0154-06 FDA Unclassified (pre-2012) initiated 10 Oct 2005

    the heat maintainer, an accessory, may overheat and deform the disposable syringe

    • Terminated Z-0257-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004

    Sterility can be compromised by a tear in the outer packaging.

    • Terminated Z-0039-05 FDA Unclassified (pre-2012) initiated 8 Oct 2004

    Sterility can be compromised by a component tearing the outer packaging

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube
Generic Name
Radiographic procedure tubing
Model / Ref / Catalog
SSS-LP-60-T
Description
"Stellant 60"" low pressure connector tube with six-inch T-connector (ASSY,FINAL,T-CON,6"",SSS-LP-60-T,MC,JA) (84196991)"
Primary DI / UDI-DI
00616258007151
510(k) Number
FDA Product Code
DXT
GMDN Term
Radiographic procedure tubing
Device Class
Class II
Regulation Number
870.1650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiographic procedure tubing

Cleared under the same submission (K023183)

Show all (12)

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Properties

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

Other properties (8)

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