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Best Medical International 1013-5-1

by Best Medical International, Inc.

Listed FDA GUDID listing, no authorization on record

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 Number00841365121388 UDI-DI Date20 Oct 2025ListedStatusListed GUDID: 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  • Withdrawn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
Best Medical International
Generic Name
Brachytherapy injection needle
Model / Reference
1013-5-1
Primary DI / UDI-DI
00841365121388
510(k) Number
FDA Product Code
KXK
GMDN Term
Brachytherapy injection needle
Device Class
Class II
Regulation Number
892.5730
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K043117)

Show all (12)

Other devices from Best Medical International, Inc.

See all devices from Best Medical International, Inc. →

Properties

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

Other properties (9)

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