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 ID07350055430387
NIH Device Record Keybae66df1-4ba2-4113-9b16-e98adb4a1a7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCERAMENT® G
Version Model NumberA0450-10
Company DUNS350066052
Company NameBone Support AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com
Phone+1.877.719.6718
Emailus.sales@bonesupport.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350055430387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QRRFiller, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-13
Device Publish Date2022-10-05

On-Brand Devices [CERAMENT® G ]

07350055430387CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u
07350055430394CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u
07350055430530CERAMENT G is an implantable bone void filler (device/ drug combination product) indicated for u
07350055430523CERAMENT 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
CERAMENT
87150885 5604069 Live/Registered
BoneSupport AB
2016-08-25
CERAMENT
CERAMENT
79020794 3298199 Live/Registered
Bone Support AB
2005-11-10
CERAMENT
CERAMENT
77192160 3571152 Live/Registered
Bone Support AB
2007-05-29

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