InterOss®

GUDID 00852072007063

SIGMAGRAFT, INC.

Dental bone matrix implant, animal-derived

• Primary Device ID: 00852072007063
• NIH Device Record Key: 46a5f489-a835-439c-b8d9-d231802cd6f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterOss®
• Version Model Number: IOLG050
• Company DUNS: 078893672
• Company Name: SIGMAGRAFT, 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: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(714)525-0114
• Email: quality.sigmagraft@sigmagraft.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852072007063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151209

FDA Product Code

• NPM: BONE GRAFTING MATERIAL, ANIMAL SOURCE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-03
• Device Publish Date: 2016-09-20

On-Brand Devices [InterOss® ]

• 00852072007018: IOSG025