Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Zimmer, Inc.
30203607
In Commercial Distribution

  • 00889024588424 ()

  • Lumen/Inner Diameter: 36.00 Millimeter
  • Size G
30203607

  • Constrained polyethylene acetabular liner
Bioactive mineral Root Canal Sealer
SEPTODONT SAS SPECIALITES SEPTODONT
01E0500
In Commercial Distribution

  • 03701398102563 ()
01E0500

  • Hygroscopic dental cement
No Description
G21 SRL
611-01-140
In Commercial Distribution

  • 08058964729026 ()


  • Orthopaedic cement, antimicrobial
No Description
G21 SRL
610-01-140
In Commercial Distribution

  • 08058964729019 ()


  • Orthopaedic cement, antimicrobial
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 CERAMENT G can also reduce the likelihood of infection subsequent to an open fracture. 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. In bone infection, CERAMENT G can also be inserted as pre-set beads.
Bone Support AB
A0535-06
In Commercial Distribution

  • 07350055430530 ()

  • Total Volume: 5 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
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 CERAMENT G can also reduce the likelihood of infection subsequent to an open fracture. 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. In bone infection, CERAMENT G can also be inserted as pre-set beads.
Bone Support AB
A0535-05
In Commercial Distribution

  • 07350055430523 ()

  • Total Volume: 10 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
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
A0450-11
In Commercial Distribution

  • 07350055430394 ()

  • Total Volume: 5 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
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
A0450-10
In Commercial Distribution

  • 07350055430387 ()

  • Total Volume: 10 Milliliter


  • Bone matrix implant, synthetic, antimicrobial
No Description
Cowellmedi Co.,Ltd
SGN453N
In Commercial Distribution

  • 08800016106862 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGH453N
In Commercial Distribution

  • 08800016106855 ()


  • Dental implant suprastructure, permanent, preformed
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