KAINOS+ K004NT

GUDID 04047844005682

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 ID: 04047844005682
• NIH Device Record Key: 0b307ec8-b5ac-46d6-aa5d-c09725294a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KAINOS+
• Version Model Number: Bone graft substitute, granules 2-3mm
• Catalog Number: K004NT
• Company DUNS: 344203948
• Company Name: SIGNUS Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49602391660
• Email: info@signus.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844005682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090387

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-11-14
• Device Publish Date: 2015-09-24

On-Brand Devices [KAINOS+]

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