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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
Zero G Eyewear
Elmsford Brown/Olive
In Commercial Distribution

  • 00840322900394 ()


  • Prescription spectacles
No Description
Zero G Eyewear
Elmsford Black
In Commercial Distribution

  • 00840322900387 ()


  • Prescription spectacles
No Description
Zero G Eyewear
Elmsford Blue/Brown
In Commercial Distribution

  • 00840322900370 ()


  • Prescription spectacles
No Description
Zero G Eyewear
Elmsford Brushed Blue Steel
In Commercial Distribution

  • 00840322900363 ()


  • Prescription spectacles
No Description
Zero G Eyewear
Daly City Tobacco UF
In Commercial Distribution

  • 00840322900356 ()


  • Prescription spectacles
No Description
Zero G Eyewear
Daly City Smoke UF
In Commercial Distribution

  • 00840322900349 ()


  • Prescription spectacles
No Description
Zero G Eyewear
Daly City Grey UF
In Commercial Distribution

  • 00840322900332 ()


  • Prescription spectacles
No Description
Zero G Eyewear
Daly City Black Navy Tort UF
In Commercial Distribution

  • 00840322900325 ()


  • Prescription spectacles
3M™ ESPE™ Cavit™-G Temporary Filling Material Refill, 44313
3M Deutschland GmbH
44313
In Commercial Distribution

  • 04035077013291 ()
44313

  • Fatty acid dental cement
Bioactive mineral Root Canal Sealer
SEPTODONT SAS SPECIALITES SEPTODONT
01E0500
In Commercial Distribution

  • 03701398102563 ()
01E0500

  • Hygroscopic dental cement
Alegra Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
10259900
In Commercial Distribution

  • J021102599000 ()
  • J021102599001 ()


  • Dental surgical power tool motorized handpiece/set, electric
Alegra Handpiece Attachment
W & H Dentalwerk Bürmoos GmbH
10256630
Not in Commercial Distribution

  • J021102566300 ()
  • J021102566301 ()


  • Dental surgical power tool motorized handpiece/set, electric
Surgical Handpiece for 3I
W & H Dentalwerk Bürmoos GmbH
10207564
Not in Commercial Distribution

  • J021102075641 ()


  • Dental surgical power tool motorized handpiece/set, electric
Surgical Handpiece
W & H Dentalwerk Bürmoos GmbH
00001120
Not in Commercial Distribution

  • J021000011201 ()


  • Dental surgical power tool motorized handpiece/set, electric
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
T-MAT G/RA 50SH 8x10in film
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889978453931 ()
  • 40889978453937 ()
  • 00889978453939 ()
8453938

  • Dental x-ray film, screen
T-MAT G/RA Film 100SH 15x30cm
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889976468463 ()
  • 40889976468469 ()
  • 00889976468461 ()
6468466

  • Dental x-ray film, screen
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