CERAMENT® G

GUDID 07350055430387

CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for use as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) where there is a need for supplemental bone graft. CERAMENT G combines gentamicin sulfate with a bone void filler, consisting of hydroxyapatite and calcium sulfate. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing. By combining calcium sulfate and hydroxyapatite, a balance is achieved between implant resorption rate and bone remodeling rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate and high osteoconductivity providing a scaffold for new bone generation. The use of CERAMENT G eliminates the need to harvest autologous bone, thereby avoiding donor site morbidity (e.g., pain, infection, etc.) in patients with a diagnosed infection. CERAMENT G may be implanted by an injectable system or inserted as pre-set beads.

Bone Support AB

Bone matrix implant, synthetic, antimicrobial

• Primary Device ID: 07350055430387
• NIH Device Record Key: bae66df1-4ba2-4113-9b16-e98adb4a1a7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMENT® G
• Version Model Number: A0450-10
• Company DUNS: 350066052
• Company Name: Bone Support AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• 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: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com
• Phone: +1.877.719.6718
• Email: us.sales@bonesupport.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350055430387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210044

FDA Product Code

• QRR: Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-13
• Device Publish Date: 2022-10-05

On-Brand Devices [CERAMENT® G ]

• 07350055430387: CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u
• 07350055430394: CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u
• 07350055430530: CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u
• 07350055430523: CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u