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Kelynaim CSI PEEK-IM1004

by Kelyniam Global Inc. 3 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817580021475 UDI-DI Date7 Dec 2016ListedStatusListed 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  • Withdrawn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
Kelynaim CSI
Generic Name
Cranioplasty plate, non-alterable
Model / Ref / Catalog
PEEK-IM1004
Primary DI / UDI-DI
00817580021475
FDA Product Code
GXN
GMDN Term
Cranioplasty plate, non-alterable
Device Class
Class II
Regulation Number
882.5330
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Related devices

Category: Cranioplasty plate, non-alterable

Other devices from Kelyniam Global Inc.

See all devices from Kelyniam Global Inc. →

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