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CastleLoc Pectus Bar System OB30-9195

by L&K Biomed Co., Ltd.

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 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809986485151 UDI-DI Date29 Oct 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  • Withdrawn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
CastleLoc Pectus Bar System
Generic name
Funnel chest remodelling bar
Model / reference
OB30-9195
Primary DI / UDI-DI
08809986485151
FDA product code
HRS
GMDN term
Funnel chest remodelling bar
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from L&K Biomed

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Lot / batch number
  • Manufacturing date

Other properties (10)

  • Supplied sterile: 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
  • Expiration date: No