Kelyniam CCI PEEK-IM2001

GUDID 00817580023998

PEEK Customized Craniofacial Implant, Small CCI040218-AE1

KELYNIAM GLOBAL, INC.

Cranioplasty plate, non-alterable
Primary Device ID00817580023998
NIH Device Record Keyd1c2d35e-fa23-43fb-8ad2-1b77ebe2796f
Commercial Distribution Discontinuation2019-08-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameKelyniam CCI
Version Model NumberPEEK-IM2001
Catalog NumberPEEK-IM2001
Company DUNS785088829
Company NameKELYNIAM GLOBAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817580023998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817580023998]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-16
Device Publish Date2019-08-08

Devices Manufactured by KELYNIAM GLOBAL, INC.

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00810125927775 - KELYNIAM CSI2025-08-18 PEEK Customized Cranial Implant, SMALL CSI061725-CF1
00810125927782 - KELYNIAM CSI2025-08-18 PEEK Customized Cranial Implant, SMALL CSI072525-DR1
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00810125927805 - KELYNIAM CSI2025-08-18 PEEK Customized Cranial Implant, X-LARGE CSI070725-IR1
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