Accell Connexus 02-3000-005

GUDID M3860230000051

Accell Connexus, 0.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accell Connexus is formulated into a putty form and is pr

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, human-derived

• Primary Device ID: M3860230000051
• NIH Device Record Key: cc1da502-c49d-4b99-953c-7b4c16724563
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accell Connexus
• Version Model Number: 02-3000-005
• Catalog Number: 02-3000-005
• 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	10889981055455 [Primary]
HIBCC	M3860230000051 [Secondary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-24

On-Brand Devices [Accell Connexus]

• M3860230001001: Accell Connexus, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. Acce
• M3860230000501: Accell Connexus, 5cc - demineralized human bone mixed with poloxamer reverse phase medium. Accel
• M3860230000251: Accell Connexus, 2.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Acc
• M3860230000101: Accell Connexus, 1cc - demineralized human bone mixed with poloxamer reverse phase medium. Accel
• M3860230000051: Accell Connexus, 0.5cc - demineralized human bone mixed with poloxamer reverse phase medium. Acc