OssiGuide

GUDID 00813954022246

Anorganic Bone Mineral (5cc)

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00813954022246
• NIH Device Record Key: 20cc7157-bfb5-4513-afdf-f58f8e3dda24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OssiGuide
• Version Model Number: PS-OG05
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00813954022246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062200

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-05

On-Brand Devices [OssiGuide]

• 00813954022253: Anorganic Bone Mineral (10cc)
• 00813954022246: Anorganic Bone Mineral (5cc)
• 00813954020303: Anorganic Bone Mineral
• 00813954020297: Anorganic Bone Mineral