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Harpoon 20X1

by Medyglobal Medical Devices Sl. 4 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 NumberB772DWFB1901 UDI-DI Date7 Jun 2021ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Harpoon
Generic Name
Composite-polymer suture
Model / Ref / Catalog
20X1, DWFB-19-01
Primary DI / UDI-DI
B772DWFB1901
510(k) Number
FDA Product Code
NEW
GMDN Term
Composite-polymer suture
Device Class
Class II
Regulation Number
878.4840
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K160761)

Show all (12)

Properties

  • Sterile
  • Single Use
  • Implantable
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No