KAINOS+ K001NT

GUDID 04047844005668

KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). KAINOS+ is available in various shapes and sizes. KAINOS+ may be used with physiolo-gical saline, patient’s own serum, whole blood, or bone marrow aspirate (BMA).

SIGNUS Medizintechnik GmbH

Bone matrix implant, synthetic
Primary Device ID04047844005668
NIH Device Record Key4ab60426-9aa5-49ac-a48e-7aba59836fad
Commercial Distribution StatusIn Commercial Distribution
Brand NameKAINOS+
Version Model NumberBone graft substitute, granules 2-3mm
Catalog NumberK001NT
Company DUNS344203948
Company NameSIGNUS Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844005668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-11-14
Device Publish Date2015-09-24

On-Brand Devices [KAINOS+]

04047844023747KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844006009KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005996KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005750KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005743KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005736KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005729KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005712KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005705KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005699KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005682KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005675KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy
04047844005668KAINOS+ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hy

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