Dynagraft II Gel 02-2000-010

GUDID M3860220000101

DynaGraft II Gel, 1cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently de

ISOTIS ORTHOBIOLOGICS, INC.

Bone matrix implant, human-derived

• Primary Device ID: M3860220000101
• NIH Device Record Key: c1f19b9e-fa40-4569-a94d-eeca83b046c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynagraft II Gel
• Version Model Number: 02-2000-010
• Catalog Number: 02-2000-010
• 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	10889981055516 [Primary]
HIBCC	M3860220000101 [Secondary]

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: 2015-09-24

On-Brand Devices [Dynagraft II Gel]

• M3860220001001: DynaGraft II Gel, 10cc - derived from selected donated human bone tissue that has been processed
• M3860220000501: DynaGraft II Gel, 5cc - derived from selected donated human bone tissue that has been processed
• M3860220000101: DynaGraft II Gel, 1cc - derived from selected donated human bone tissue that has been processed
• M3860220000051: DynaGraft II Gel, 0.5cc - derived from selected donated human bone tissue that has been processe