Kelyniam CSI PEEK-IM1002

GUDID 00817580027538

PEEK Customized Cranial Implant, Medium CSI071720-LL1

KELYNIAM GLOBAL, INC.

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable
Primary Device ID00817580027538
NIH Device Record Key65074c83-f559-49ab-ad71-072ea84c7a13
Commercial Distribution Discontinuation2020-07-22
Commercial Distribution StatusNot in Commercial Distribution
Brand NameKelyniam CSI
Version Model NumberPEEK-IM1002
Catalog NumberPEEK-IM1002
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
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]
GS100817580027538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


[00817580027538]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [Kelyniam CSI ]

00817580023127PEEK Customized Cranial Implant, X-Large
00817580023110PEEK Customized Cranial Implant, X-Large
00817580023103PEEK Customized Cranial Implant, X-Large
00817580023097PEEK Customized Cranial Implant, Medium
00817580023080PEEK Customized Cranial Implant, Large
00817580023073PEEK Customized Cranial Implant, X-Large
00817580023066PEEK Customized Cranial Implant, Small
00817580023059PEEK Customized Cranial Implant, X-Large
00817580023042PEEK Customized Cranial Implant, X-Large
00817580023035PEEK Customized Cranial Implant, X-Large
00817580023028PEEK Customized Cranial Implant, X-Large & Medium
00817580023011PEEK Customized Cranial Implant, Medium
00817580023004PEEK Customized Cranial Implant, X-Large
00817580022991PEEK Customized Cranial Implant, X-Large
00817580022984PEEK Customized Cranial Implant, X-Large
00817580022977PEEK Customized Cranial Implant, Large
00817580022953PEEK Customized Cranial Implant, X-Large
00817580022946PEEK Customized Cranial Implant, Medium
00817580022939PEEK Customized Cranial Implant, Medium
00817580022922PEEK Customized Cranial Implant, X-Large
00817580022915PEEK Customized Cranial Implant, X-Large
00817580022908PEEK Customized Cranial Implant, Large
00817580022892PEEK Customized Cranial Implant, Small
00817580022885PEEK Customized Cranial Implant, X-Large
00817580022878PEEK Customized Cranial Implant, Medium
00817580022861PEEK Customized Cranial Implant, Small
00817580022854PEEK Customized Cranial Implant, Large
00817580022847PEEK Customized Cranial Implant, X-Large
00817580022830PEEK Customized Cranial Implant, X-Large
00817580022823PEEK Customized Cranial Implant, X-Large
00817580022816PEEK Customized Cranial Implant, X-Large
00817580022809PEEK Customized Cranial Implant, X-Large
00817580022793PEEK Customized Cranial Implant, X-Large
00817580022786PEEK Customized Cranial Implant, X-Large
00817580022779PEEK Customized Cranial Implant, Large
00817580022762PEEK Customized Cranial Implant, X-Large
00817580022755PEEK Customized Cranial Implant, Medium
00817580022748PEEK Customized Cranial Implant, Large
00817580022731PEEK Customized Cranial Implant, X-Large & Medium
00817580022724PEEK Customized Cranial Implant, Large
00817580022700PEEK Customized Cranial Implant, X-Large
00817580022694PEEK Customized Cranial Implant, Large
00817580022687PEEK Customized Cranial Implant, Medium
00817580022670PEEK Customized Cranial Implant, Large
00817580022663PEEK Customized Cranial Implant, Medium
00817580022656PEEK Customized Cranial Implant, X-Large
00817580022649PEEK Customized Cranial Implant, Large
00817580022625PEEK Customized Cranial Implant, Large
00817580022618PEEK Customized Cranial Implant, Small
00817580022601PEEK Customized Cranial Implant, Large

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.