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TAVR Removal Set 2400-200-SET

by Sontec Instruments, Inc.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00192896123762 UDI-DI Date18 Sep 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  • Withdrawn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
TAVR Removal Set
Generic Name
Cardiothoracic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog
2400-200-SET
Primary DI / UDI-DI
00192896123762
FDA Product Code
DWS
GMDN Term
Cardiothoracic surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
870.4500
GUDID distribution status
In Commercial Distribution
Sterilization Method
Dry Heat Sterilization

Other devices from Sontec Instruments, Inc.

See all devices from Sontec Instruments, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No