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Ips 60-011-18-09-LP

by KLS-Martin L.P.

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 Number00888118145864 UDI-DI Date1 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  • Withdrawn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
Ips
Generic name
Custom-made cranial bone prosthesis
Model / reference
60-011-18-09-LP
Primary DI / UDI-DI
00888118145864
FDA product code
ELE
GMDN term
Custom-made cranial bone prosthesis
Device class
Class II
Regulation number
872.3645
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Other devices from KLS-Martin L.P.

See all devices from KLS-Martin L.P. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number

Other properties (9)

  • Supplied sterile: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No
  • Manufacturing date: No