IsoTis Mozaik Moldable Morsels MSL015

GUDID M269MSL0151

IsoTis Mozaik™ Moldable Morsels Mini, 1.5cc - A resorbable bone void filler made from microfibrillar collagen combined with tricalcium phosphate (TC

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, composite

• Primary Device ID: M269MSL0151
• NIH Device Record Key: f62ba2de-d260-44a2-8de6-af720b2f2bfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IsoTis Mozaik Moldable Morsels
• Version Model Number: MSL015
• Catalog Number: MSL015
• Company DUNS: 801089152
• Company Name: ISOTIS ORTHOBIOLOGICS, INC.
• 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: false
• 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: +1(800)550-7155
• Email: Irvine.customerservice@seaspin
• Phone: +1(800)550-7155
• Email: Irvine.customerservice@seaspin

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981056032 [Primary]
HIBCC	M269MSL0151 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091302

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [IsoTis Mozaik Moldable Morsels]

• M269MSL1501: IsoTis Mozaik™ Moldable Morsels Mega, 2 X 7.5cc - A resorbable bone void filler made from mic
• M269MSL0751: IsoTis Mozaik™ Moldable Morsels Max, 7.5cc - A resorbable bone void filler made from microfib
• M269MSL0301: IsoTis Mozaik™ Moldable Morsels Mid, 3cc - A resorbable bone void filler made from microfibri
• M269MSL0151: IsoTis Mozaik™ Moldable Morsels Mini, 1.5cc - A resorbable bone void filler made from microfi