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Customized Skull Implant (Csi) Peek-IM1002

by Kelyniam Global Inc. GUDID 5 variants

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810125929939 UDI-DIDate13 Jul 2026ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Customized Skull Implant (Csi)
Generic Name
Cranioplasty plate, alterable
Model / Ref / Catalog
PEEK-IM1002
Description
PEEK Customized Skull Implant, MEDIUM CSI050626-DR1
Primary DI / UDI-DI
00810125929939
510(k) Number
FDA Product Code
GWO
GMDN Term
Cranioplasty plate, alterable
Device Class
Class II
Regulation Number
882.5320
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

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Properties

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

Other properties (7)

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