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SAPIEN Stabilizer Rail System 9880SRS

by Edwards Lifesciences LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00690103219807 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SAPIEN Stabilizer Rail System
Generic Name
Cardiac implantation catheter holder, single-use
Model / Ref / Catalog
9880SRS, 9880SRSA
Primary DI / UDI-DI
00690103219807
FDA Product Code
QWA
GMDN Term
Cardiac implantation catheter holder, single-use
Device Class
Class I
Regulation Number
870.3955
GUDID distribution status
In Commercial Distribution

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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