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Rivacor Sky VR-T DX 481983

by BIOTRONIK SE & Co. KG GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04035479182779 UDI-DIDate20 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Rivacor Sky VR-T DX
Generic Name
Single-chamber implantable defibrillator
Model / Ref / Catalog
481983
Primary DI / UDI-DI
04035479182779
FDA Product Code
LWS
GMDN Term
Single-chamber implantable defibrillator
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No