Arthrex ABS-2013-01

GUDID 10889981153588

AlloSync DBM Gel, 1cc Syringe

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, human-derived

• Primary Device ID: 10889981153588
• NIH Device Record Key: b936634e-5d95-4f91-b1da-9675fc28ad57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arthrex
• Version Model Number: ABS-2013-01
• Catalog Number: ABS-2013-01
• 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	10889981153588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040419

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: 2017-11-17

On-Brand Devices [Arthrex]

• 10889981153694: AlloSync CB DBM Putty, 10cc Vial
• 10889981153687: AlloSync CB DBM Putty, 5cc Vial
• 10889981153670: AlloSync CB DBM Paste, 8cc Syringe
• 10889981153663: AlloSync CB DBM Paste, 3cc Syringe
• 10889981153656: AlloSync CB DBM Paste, 1cc Syringe
• 10889981153649: AlloSync DBM Putty, 10cc Vial
• 10889981153632: AlloSync DBM Putty, 5cc Vial
• 10889981153625: AlloSync DBM Putty, 2.5cc Vial
• 10889981153618: AlloSync DBM Putty, 1cc Vial
• 10889981153601: AlloSync DBM Gel, 10cc Syringe
• 10889981153595: AlloSync DBM Gel, 5cc Syringe
• 10889981153588: AlloSync DBM Gel, 1cc Syringe