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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The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of incubation. MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria. Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label: Gram-positive bacteria Enterococcus faecalis Enterococcus faecium Staphylococcus aureus Gram-negative bacteria Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label: Citrobacter koseri Klebsiella (Enterobacter) aerogenes
LIOFILCHEM SRL
Eravacycline ERV 0.002-32 µg/mL 10 STRIP
In Commercial Distribution

  • 18055182872906 ()
  • 08055182872909 ()
  • 08055182872886 ()
92104-10

  • Eravacycline minimum inhibitory concentration (MIC) IVD
The Liofilchem® MTS™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µglmL of antimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Eravacycline at concentrations of 0.002-32 µglmL should be interpreted at 16-20 hours of incubation. MTS™ Eravacycline can be used to dete1mine the MIC of eravacycline against the following bacteria. Eravacycline has been shown to be active both clinically and in vitro against these bacterial species accoring to the FDA drug approved label: Gram-positive bacteria Enterococcus faecalis Enterococcus faecium Staphylococcus aureus Gram-negative bacteria Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below accoring to the FDA drug aprroved label: Citrobacter koseri Klebsiella (Enterobacter) aerogenes
LIOFILCHEM SRL
Eravacycline ERV 0.002-32 µg/mL 1 STRIP
In Commercial Distribution

  • 08055182872893 ()
  • 28055182872897 ()
  • 18055182872890 ()
92104-1

  • Eravacycline minimum inhibitory concentration (MIC) IVD
MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
LIOFILCHEM SRL
PENICILLIN G P 0.002-32 µg/mL 1 Strip
In Commercial Distribution

  • 28055182872866 ()
  • 08055182872862 ()
  • 18055182872869 ()
$92103-1

  • Penicillin G minimum inhibitory concentration (MIC) IVD
No Description
LIOFILCHEM SRL
Imipenem-relebactam I/R 0.002/4-32/4 10 Strip
In Commercial Distribution

  • 18055182872487 ()
  • 08055182872480 ()
  • 08055182872466 ()
$92076-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
No Description
LIOFILCHEM SRL
Imipenem-relebactam I/R 0.002/4-32/4, 1 Strip
In Commercial Distribution

  • 28055182872477 ()
  • 08055182872473 ()
  • 18055182872470 ()
$92076-01

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
No Description
LIOFILCHEM SRL
Omadacycline 0.002-32 µg/mL, 1 Strip
In Commercial Distribution

  • 18055182872388 ()
  • 08055182872381 ()
  • 28055182872385 ()
$92071-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
The Liofilchem® MTS™ (MIC Test Strip) is a quantitative method intended for the in vitro determination ofantimicrobial susceptibility of bacteria MTS™ consists ofspecialized papyr impregnated with a pre-defined concentration gradient ofan antimicrobial agent, which is used to determine the minimum inhibitozy concentration (MIC) in µglmL ofantimicrobial agents against bacteria as tested on agar media using ovemight incubation and manual reading procedures. The MTS™ Plazomicin at concentrations of0.016-256 µglmL should be interpreted at 16-20 hours of incubation. MTS™ PLZ can be used to dete1mine the MIC ofplazomicin against the microorganisms listed below: Plazomicin Activity According to the FDA Label Clinical and in vitro Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Proteus mirabilis in vitro only Citrobacterfreundii Citrobacter koseri Klebsiella (Enterobacter) aerogenes Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia stuartii Serratia marcescens
LIOFILCHEM SRL
Plazomicin 0.016-256 µg/mL
In Commercial Distribution

  • 08055182872367 ()
  • 08055182872343 ()
  • 18055182872364 ()
$92070-10

  • Plazomicin minimum inhibitory concentration (MIC) IVD
No Description
LIOFILCHEM SRL
Imipenem IMI 0.016-256 µg/ml 10 Strip
In Commercial Distribution

  • 18055182872302 ()
  • 08055182872305 ()
  • 08055182872282 ()
$92068-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
No Description
LIOFILCHEM SRL
Imipenem IMI 0.016-256 µg/ml, 1 Strip
In Commercial Distribution

  • 28055182872293 ()
  • 08055182872299 ()
  • 18055182872296 ()
$92068-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
No Description
LIOFILCHEM SRL
Lefamulin LMU 0.016-256 µg/ml, 1 Strip
In Commercial Distribution

  • 18055182872173 ()
  • 08055182872176 ()
  • 28055182872170 ()
$92064-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
No Description
LIOFILCHEM SRL
Gentamicin 0.016-256 µg/mL, 10 Strip
In Commercial Distribution

  • 18055182870629 ()
  • 08055182870622 ()
  • 08055182870608 ()
$92009-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem-vaborbactam M/V 0.016/8 - 256/8 are specialized strips impregnated with a predefined concentration gradient of Meropenem-vaborbactam for susceptibility testing of Enterobacter cloacae species complex, Escherichia coli, Klebsiella pneumoniae
LIOFILCHEM SRL
Meropenem-vaborbactam M/V 0.016/8 - 256/8 - 10 strips
In Commercial Distribution

  • 18055182870322 ()
  • 08055182870325 ()
  • 08055182870301 ()
$92074-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Erythromycin 0.016 - 256μg/m are specialized strips impregnated with a predefined concentration gradient of Erythromycin for susceptibility testing of Staphylococcus aureus.
LIOFILCHEM SRL
Erythromycin 0.016 - 256μg/mL 10 strips
In Commercial Distribution

  • 18055182870292 ()
  • 08055182870295 ()
  • 08055182870271 ()
$92051-10

  • Erythromycin minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Delafloxacin 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Delafloxacin for susceptibility testing of Staphylococcus aureus (including methicillin-resistant and methicillin-susceptibleisolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Enterococcus faecalis
LIOFILCHEM SRL
Delafloxacin 0.002-32 µg/mL 10 strips
In Commercial Distribution

  • 18055182870261 ()
  • 08055182870264 ()
  • 08055182870240 ()
$92080-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime 0.016-256 are specialized strips impregnated with a predefined concentration gradient of Ceftazidime for susceptibility testing of Citrobacter species, Enterobacter species, Escherichia coli, Klebsiella species, Proteus mirabilis, Proteus vulgarism, Pseudomonas aeruginosa
LIOFILCHEM SRL
Ceftazidime 0.016-256 µg/mL 10 strips
In Commercial Distribution

  • 18055182870209 ()
  • 08055182870202 ()
  • 08055182870189 ()
$92138-10

  • Ceftazidime minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Tedizolid 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Tedizolid for susceptibility testing of Staphylococcus aureus (including methicillin resistant and methicillin susceptible isolates) and Enterococcus faecalis.
LIOFILCHEM SRL
Tedizolid 0.002-32 µg/mL 10 strips
In Commercial Distribution

  • 18055182870179 ()
  • 08055182870172 ()
  • 08055182870158 ()
$92136-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Clindamycin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Clindamycin for susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains).
LIOFILCHEM SRL
Clindamycin 0.016-256 µg/mL 1 strip
In Commercial Distribution

  • 28055182870138 ()
  • 08055182870134 ()
  • 18055182870131 ()
$92072-1

  • Clindamycin minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Meropenem 0.002-32 μg/mL 1 strip
In Commercial Distribution

  • 28055182870107 ()
  • 08055182870103 ()
  • 18055182870100 ()
$92084-1

  • Meropenem minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 10 strips
In Commercial Distribution

  • 18055182870087 ()
  • 08055182870080 ()
  • 08055182870066 ()
$92146-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Vancomycin 0.016-256 μg/mL are specialized strips impregnated with a predefined concentration gradient of vancomycin for susceptibility testing of nonfastidious species, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis and Enterococcus faecium.
LIOFILCHEM SRL
Vancomycin 0.016-256 µg/ml 10 strips
In Commercial Distribution

  • 18055182870056 ()
  • 08055182870059 ()
  • 08055182870035 ()
$92057-10

  • Vancomycin minimum inhibitory concentration (MIC) IVD
MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Dalbavancin 0.002-32 μg/ml are specialized strips impregnated with a predefined concentration gradient of dalbavancin for susceptibility testing of Staphylococcus aureus and Enterococcus faecalis
LIOFILCHEM SRL
Dalbavancin 0.002-32 µg/ml 10 strips
In Commercial Distribution

  • 18055182870025 ()
  • 08055182870028 ()
  • 08055182870004 ()
$92137-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit
No Description
TSUNAMI SRL
TVN 11/15
In Commercial Distribution

  • 08055060728786 ()


  • Vertebral bone biopsy procedure kit, single-use
Intra oral scanner for digital impression of Dental restoration
TRIDENT SRL
Imagen Scan
In Commercial Distribution

  • 08055060430955 ()
TSC002

  • Intraoral optical scanning system
Intra oral scanner for digital impression of Dental restoration
TRIDENT SRL
TriScan
In Commercial Distribution

  • 08055060430948 ()
TSC001

  • Intraoral optical scanning system
DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
TRIDENT SRL
Size 2
In Commercial Distribution

  • 08055060430450 ()
IS039-DL

  • Dental digital imaging sensor, intraoral
DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
TRIDENT SRL
Size 1
In Commercial Distribution

  • 08055060430443 ()
IS038-DL

  • Dental digital imaging sensor, intraoral
DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
TRIDENT SRL
Size 2
In Commercial Distribution

  • 08055060430436 ()
IS035-DL

  • Dental digital imaging sensor, intraoral
DIGITAL INTRAORAL VIDEORADIOGRAPHY SYSTEMS
TRIDENT SRL
Size 1
In Commercial Distribution

  • 08055060430429 ()
IS034-DL

  • Dental digital imaging sensor, intraoral
Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
TRIDENT SRL
Size 2
In Commercial Distribution

  • 08055060430412 ()

  • Width: 31.3 Millimeter
  • Length: 42.9 Millimeter
  • Height: 4.8 Millimeter
IS029-DL

  • Dental digital imaging sensor, intraoral
Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
TRIDENT SRL
Size 1
In Commercial Distribution

  • 08055060430405 ()

  • Width: 25.4 Millimeter
  • Length: 36.8 Millimeter
  • Height: 4.8 Millimeter
IS028-DL

  • Dental digital imaging sensor, intraoral
Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
TRIDENT SRL
Size 2
In Commercial Distribution

  • 08055060430313 ()

  • Length: 42.9 Millimeter
  • Width: 25.4 Millimeter
  • Height: 4.8 Millimeter
IS019-S

  • Dental digital imaging sensor, intraoral
Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
TRIDENT SRL
Size 1
In Commercial Distribution

  • 08055060430306 ()

  • Width: 25.4 Millimeter
  • Length: 36.8 Millimeter
  • Height: 4.8 Millimeter
IS018-S

  • Dental digital imaging sensor, intraoral
Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
TRIDENT SRL
size 2
In Commercial Distribution

  • 08055060430290 ()

  • Width: 31.3 Millimeter
  • Length: 42.9 Millimeter
  • Height: 4.8 Millimeter
IS015-S

  • Dental digital imaging sensor, intraoral
Digital intra oral sensor for radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
TRIDENT SRL
size 1
In Commercial Distribution

  • 08055060430283 ()

  • Width: 25.4 Millimeter
  • Length: 36.8 Millimeter
  • Height: 4.8 Millimeter
IS014-S

  • Dental digital imaging sensor, intraoral
The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of teeth and adjacent structures.
TRIDENT SRL
Wall mount long arm
In Commercial Distribution

  • 08055060430221 ()
RiX70 DC-100

  • Stationary intraoral dental x-ray system, digital
The RiX 70 DC Mobile is an X-Ray source to produce intraoral images for the diagnosis of teeth and adjacent structures.
TRIDENT SRL
Mobile version
In Commercial Distribution

  • 08055060430191 ()
RIX70DC-000

  • Mobile intraoral dental x-ray system, digital
The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of teeth and adjacent structures.
TRIDENT SRL
Wall mount middle arm
In Commercial Distribution

  • 08055060430177 ()
RiX70 DC-080

  • Stationary intraoral dental x-ray system, digital
The RiX 70 DC Wall is a stationary X-Ray source to produce intraoral images for the diagnosis of teeth and adjacent structures.
TRIDENT SRL
Wall mount short arm
In Commercial Distribution

  • 08055060430160 ()
RiX70 DC-060

  • Stationary intraoral dental x-ray system, digital
Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution

  • 78055060110344 ()
  • 08055060110345 ()
CPRO401-US

  • Endoscopic video image interpretive software
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution

  • 08055060110338 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution

  • 08055060110321 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution

  • 08055060110314 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution

  • 78055060110290 ()
  • 08055060110291 ()


  • Endoscopic video image interpretive software
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution

  • 08055060110185 ()
FS01

  • Foot-switch, electrical
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution

  • 08055060110178 ()
UKS01

  • Foot-switch, electrical
BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure. BIOPAD® is a sponge-shaped device, constituted exclusively by lyophilized type I native heterologous collagen extracted from horse flexor tendon. When applied to a wound, BIOPAD® constitutes a barrier for the wound against exogenous infective agents. BIOPAD® is the ideal first-aid means to control minor bleeding. The device may be used by healthcare professionals. BIOPAD® is supplied sterile and for one-time use only.
EURORESEARCH SRL
4x4
In Commercial Distribution

  • 08054953400112 ()


  • Animal-derived wound matrix dressing
BIOPAD® is a wound dressing for topical use to control minor bleedings and for the management of any kind of ulcer and skin lesion to help wound closure. BIOPAD® is a sponge-shaped device, constituted exclusively by lyophilized type I native heterologous collagen extracted from horse flexor tendon. When applied to a wound, BIOPAD® constitutes a barrier for the wound against exogenous infective agents. BIOPAD® is the ideal first-aid means to control minor bleeding. The device may be used by healthcare professionals. BIOPAD® is supplied sterile and for one-time use only.
EURORESEARCH SRL
2x2
In Commercial Distribution

  • 08054953400105 ()


  • Animal-derived wound matrix dressing
Transporter / driver 16 short steel
SAEG SRL
Non-invasive
In Commercial Distribution

  • 08054754742589 ()
005.017-S

  • Surgical screwdriver, reusable
Transporter / driver 16 long steel
SAEG SRL
Non-invasive
In Commercial Distribution

  • 08054754742572 ()
005.016-S

  • Surgical screwdriver, reusable
Countersink 12 - steel
SAEG SRL
FAB-1878
In Commercial Distribution

  • 08054754741735 ()
FAB-1878

  • Fixture/appliance dental drill bit, reusable
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