OSSEOGUARD®

Basic Information

• Brand Name: OSSEOGUARD®
• Primary DI: 00844868041771
• Version / Model: TR150RAX-2
• Company Name: BIOMET 3I, LLC
• Labeler DUNS: 186127825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-01-31
• Public Version: 3
• Public Version Date: 2022-03-10
• Public Version Status: Update
• Public Device Record Key: e8c29ad1-5d23-40f4-990f-bf16d792b893

Device Description

OSSEOGUARD® PTFE TR150 30 X 40 RIDGE AUGMENTATION X - 2 UNIT BOX

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone grafting material, synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62481	Pliable-polymer dental regeneration membrane, non-bioabsorbable	A sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844868041771	GS1
Unit of Use	30844868041772	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	30	Millimeter
Length	40	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius