OsteoSurge 100 Putty 56300010

GUDID M386563000101

OsteoSurge100, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, human-derived Bone matrix implant, human-derived

• Primary Device ID: M386563000101
• NIH Device Record Key: ae87e125-c108-46b6-91ed-918cc51cb41f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsteoSurge 100 Putty
• Version Model Number: 56300010
• Catalog Number: 56300010
• 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: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981055790 [Primary]
HIBCC	M386563000101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061880

FDA Product Code

• MBP: Filler, bone void, osteoinduction (w/o human growth factor)

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 [OsteoSurge 100 Putty]

• M386563001001: OsteoSurge100, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoS
• M386563000501: OsteoSurge100, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSu
• M386563000251: OsteoSurge100, 2.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Osteo
• M386563000101: OsteoSurge100, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSu