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Heartline Stabilizer Arm 2800-814

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 Number00192896114449 UDI-DI Date3 Feb 2023ListedStatusListed 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  • Withdrawn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
Heartline Stabilizer Arm
Generic Name
Surgical retractor/retraction system blade, reusable
Model / Ref / Catalog
2800-814
Primary DI / UDI-DI
00192896114449
FDA Product Code
MWS
GMDN Term
Surgical retractor/retraction system blade, reusable
Device Class
Class I
Regulation Number
870.4500
GUDID distribution status
In Commercial Distribution

Other devices from Sontec Instruments, Inc.

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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