CERAMENT® G
GUDID 07350055430530
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 | 07350055430530 |
| NIH Device Record Key | 3ccb6454-a60e-439b-adcb-f1e397f53057 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CERAMENT® G |
| Version Model Number | A0535-06 |
| 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 | 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 |
Customer Support Contacts
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com | |
| Phone | +1.877.719.6718 |
| us.sales@bonesupport.com |
Device Dimensions
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 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 |
| 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 | 07350055430530 [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 | 2024-02-09 |
| Device Publish Date | 2024-02-01 |
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 |
Trademark Results [CERAMENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERAMENT 87150885 5604069 Live/Registered |
BoneSupport AB 2016-08-25 |
 CERAMENT 79020794 3298199 Live/Registered |
Bone Support AB 2005-11-10 |
 CERAMENT 77192160 3571152 Live/Registered |
Bone Support AB 2007-05-29 |
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