Optium® TGEL03

GUDID 00889858625708

Optium DBM Gel, 3 cc

LIFENET HEALTH

Bone matrix implant, human-derived

• Primary Device ID: 00889858625708
• NIH Device Record Key: 8c779264-b52a-405a-9e02-96a969be388a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optium®
• Version Model Number: TGEL03
• Catalog Number: TGEL03
• Company DUNS: 121828156
• Company Name: LIFENET HEALTH
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889858625708 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-15
• Device Publish Date: 2020-12-07

On-Brand Devices [Optium®]

• 00889858517744: Optium DBM Putty
• 00889858517720: Optium DBM Putty
• 00889858517706: Optium DBM Putty
• 00889858517683: Optium DBM Putty
• 00889858450584: Optium DBM Gel
• 00889858450560: Optium DBM Gel
• 00889858450546: Optium DBM Gel
• 00889858625708: Optium DBM Gel, 3 cc