CERAMENT™BONE VOID FILLER A0210-08

GUDID 07350055430035

Bone Support AB

Bone matrix implant, synthetic

• Primary Device ID: 07350055430035
• NIH Device Record Key: a98f4ab6-db42-4a11-97fd-226e61cf8674
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMENT™BONE VOID FILLER
• Version Model Number: A0210-08
• Catalog Number: A0210-08
• Company DUNS: 350066052
• Company Name: Bone Support AB
• 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: true
• 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

• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350055430035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073316

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: 4
• Public Version Date: 2018-12-06
• Device Publish Date: 2015-09-17

On-Brand Devices [CERAMENT™BONE VOID FILLER ]

• 07350055430066: A0210-11
• 07350055430042: A0210-09
• 07350055430035: A0210-08