RegenaVate™ Formable DBM RT, 2cc 005302Z

GUDID 00191083045115

Rti Surgical, Inc.

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

• Primary Device ID: 00191083045115
• NIH Device Record Key: 54634cb3-3420-4789-8942-8b21ebcf08f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RegenaVate™ Formable DBM RT, 2cc
• Version Model Number: ZR0202
• Catalog Number: 005302Z
• Company DUNS: 117560455
• Company Name: Rti Surgical, 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191083045115 [Primary]
GS1	00854095006771 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080418

FDA Product Code

• NUN: BONE GRAFTING MATERIAL, HUMAN SOURCE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-04
• Device Publish Date: 2024-05-27

On-Brand Devices [RegenaVate™ Formable DBM RT, 2cc]

• 00854095006771: Formable DBM RT, 2cc
• 00191083045115: ZR0202