Optium® TGEL05

GUDID 00889858450560

Optium DBM Gel

LIFENET HEALTH

Bone matrix implant, human-derived

• Primary Device ID: 00889858450560
• NIH Device Record Key: ebebbaf5-d099-48ef-8e48-bdce53c8e810
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optium®
• Version Model Number: TGEL05
• Catalog Number: TGEL05
• 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

Customer Support Contacts

• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx
• Phone: 1-888-847-7831
• Email: xx@xx.xx

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 Identifiers

Device Issuing Agency	Device ID
GS1	00889858450560 [Primary]

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: 3
• Public Version Date: 2020-12-10
• Device Publish Date: 2015-09-24

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