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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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InTray® Malt Extract Agar - B08813330

A nutrient-rich medium for the use of cultivation, isolation and enumeration of a broad-spectrum of environmental and pathogenic yeasts and molds. The device can accept samples by direct plating or interface directly with standard methods for microbial testing of water samples using the Membrane Filter (MF) Technique1. The acidic pH of Malt Extract Agar allows for the optimal growth of molds and yeasts while restricting bacterial growth.
BIO-MED DIAGNOSTICS, INC.
1333
In Commercial Distribution

  • B08813334 ()
  • B08813330 ()
  • B08813332 ()
21-333-001

  • Malt extract agar culture medium IVD

InTray® MSA - B08813030

Mannitol Salt Agar (MSA) test uses a selective isolation media for the enumeration of staphylococci from clinical/non-clinical materials. A change of the phenol red indicator (Mannitol fermentation) aids in differentiating staphylococci species.
BIO-MED DIAGNOSTICS, INC.
1303
In Commercial Distribution

  • B08813034 ()
  • B08813030 ()
  • B08813032 ()
21-303-001

  • Mannitol-salt Staphylococcus species agar culture medium IVD

InTray® PDA - B08812930

Recommended by the American Public Health Association for plate counts of yeasts and molds in the examination of foods and dairy products, it is also used for maintenance, cultivation and sporulation of stock cultures of various dermatophytes and for differentiation of atypical varieties of dermatophytes by pigment production.
BIO-MED DIAGNOSTICS, INC.
1293
In Commercial Distribution

  • B08812934 ()
  • B08812930 ()
  • B08812932 ()
21-293-001

  • Potato-dextrose fungal agar culture medium IVD

InTray® SAB - B08812630

A general-purpose medium for the cultivation of pathogenic and non-pathogenic fungi, including dermatophytes. The low pH (approximately 5.6) is favorable for growth of fungi, especially yeasts and dermatophytes. Sabouraud's Dextrose Agar (SAB) is slightly inhibitory to contaminating bacteria in clinical specimens.
BIO-MED DIAGNOSTICS, INC.
1263
In Commercial Distribution

  • B08812634 ()
  • B08812630 ()
  • B08812632 ()
21-263-001

  • Basic/simple nutrient agar culture medium IVD

InTray® COLOREX Salmonella - B08812230

A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
BIO-MED DIAGNOSTICS, INC.
1223
In Commercial Distribution

  • B08812234 ()
  • B08812230 ()
  • B08812232 ()
21-223-001

  • Chromogenic Salmonella species agar culture medium IVD

InTray® COLOREX Yeast - B08811130

For isolation and differentiation of major clinically significant Candida species. Suitable for direct streaking of samples from skin,sputum, urine or genitourinary swabs.
BIO-MED DIAGNOSTICS, INC.
1113
In Commercial Distribution

  • B08811134 ()
  • B08811130 ()
  • B08811132 ()
21-113-001

  • Multiple Candida/yeast species culture isolate identification IVD, kit

InTray® COLOREX Screen - B08811030

For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
BIO-MED DIAGNOSTICS, INC.
1103
In Commercial Distribution

  • B08811034 ()
  • B08811030 ()
  • B08811032 ()
21-103-001

  • Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid

InPouch® TV - B08810310

Self-contained media system for the recovery and detection of T. vaginalis from female vaginal samples or male urethra/urine samples.
BIO-MED DIAGNOSTICS, INC.
1031
In Commercial Distribution

  • B08810310 ()
  • B08810317 ()
  • B08810313 ()
21-031-001

  • Differential/selective broth culture medium IVD

Monoart - E3072640060

A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: lime
EURONDA SPA
KIT MONOART DENTIST CHAIR COVER
In Commercial Distribution

  • E3072640060 ()
  • E3072640062 ()
  • E3072640061 ()
264006

  • Medical equipment drape, single-use, non-sterile

Monoart - E3072640050

A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: lilac
EURONDA SPA
KIT MONOART DENTIST CHAIR COVER
In Commercial Distribution

  • E3072640050 ()
  • E3072640052 ()
  • E3072640051 ()
264005

  • Medical equipment drape, single-use, non-sterile

Monoart - E307229310090

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: burgundy
EURONDA SPA
MONOART EM21
In Commercial Distribution

  • E307229310092 ()
  • E307229310091 ()
  • E307229310090 ()
22931009

  • Dental suction system cannula, reusable

Monoart - E307229310080

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: green
EURONDA SPA
MONOART EM21
In Commercial Distribution

  • E307229310082 ()
  • E307229310081 ()
  • E307229310080 ()
22931008

  • Dental suction system cannula, reusable

Monoart - E307229310070

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: pink
EURONDA SPA
MONOART EM21
In Commercial Distribution

  • E307229310072 ()
  • E307229310071 ()
  • E307229310070 ()
22931007

  • Dental suction system cannula, reusable

Monoart - E307229310060

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: lime
EURONDA SPA
MONOART EM21
In Commercial Distribution

  • E307229310062 ()
  • E307229310061 ()
  • E307229310060 ()
22931006

  • Dental suction system cannula, reusable

Monoart - E307229310040

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: yellow
EURONDA SPA
MONOART EM21
In Commercial Distribution

  • E307229310042 ()
  • E307229310041 ()
  • E307229310040 ()
22931004

  • Dental suction system cannula, reusable

Monoart - E307229310020

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilizedin autoclaves at up to 134°C. Connection diameter:16 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: orange
EURONDA SPA
MONOART EM21
In Commercial Distribution

  • E307229310022 ()
  • E307229310021 ()
  • E307229310020 ()
22931002

  • Dental suction system cannula, reusable

Monoart - E307229300090

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilized in autoclaves at up to 134°C. Connection diameter:16 mm. Length: 114 mm. Box of 10 pieces of the same colour. Colour: burgundy
EURONDA SPA
MONOART EM19
In Commercial Distribution

  • E307229300092 ()
  • E307229300091 ()
  • E307229300090 ()
22930009

  • Dental suction system cannula, reusable

Monoart - E307229300080

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilized in autoclaves at up to 134°C. Connection diameter:16 mm. Length: 114 mm. Box of 10 pieces of the same colour. Colour: green
EURONDA SPA
MONOART EM19
In Commercial Distribution

  • E307229300082 ()
  • E307229300081 ()
  • E307229300080 ()
22930008

  • Dental suction system cannula, reusable

Monoart - E307229300070

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilized in autoclaves at up to 134°C. Connection diameter:16 mm. Length: 114 mm. Box of 10 pieces of the same colour. Colour: pink
EURONDA SPA
MONOART EM19
In Commercial Distribution

  • E307229300072 ()
  • E307229300071 ()
  • E307229300070 ()
22930007

  • Dental suction system cannula, reusable

Monoart - E307229300060

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilized in autoclaves at up to 134°C. Connection diameter:16 mm. Length: 114 mm. Box of 10 pieces of the same colour. Colour: lime
EURONDA SPA
MONOART EM19
In Commercial Distribution

  • E307229300062 ()
  • E307229300061 ()
  • E307229300060 ()
22930006

  • Dental suction system cannula, reusable

Monoart - E307229300050

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilized in autoclaves at up to 134°C. Connection diameter:16 mm. Length: 114 mm. Box of 10 pieces of the same colour. Colour: lilac
EURONDA SPA
MONOART EM19
In Commercial Distribution

  • E307229300052 ()
  • E307229300051 ()
  • E307229300050 ()
22930005

  • Dental suction system cannula, reusable

Monoart - E307229300040

Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilized in autoclaves at up to 134°C. Connection diameter:16 mm. Length: 114 mm. Box of 10 pieces of the same colour. Colour: yellow
EURONDA SPA
MONOART EM19
In Commercial Distribution

  • E307229300042 ()
  • E307229300041 ()
  • E307229300040 ()
22930004

  • Dental suction system cannula, reusable

Monoart - E307220103150

Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: pink
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103151 ()
  • E307220103152 ()
  • E307220103150 ()
22010315

  • Patient examination/treatment drape, single-use

Monoart - E307220103140

Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: lilac
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103141 ()
  • E307220103142 ()
  • E307220103140 ()
22010314

  • Patient examination/treatment drape, single-use

Monoart - E307220103120

Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: orange
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103121 ()
  • E307220103122 ()
  • E307220103120 ()
22010312

  • Patient examination/treatment drape, single-use

Monoart - E307220103110

Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: blue
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103111 ()
  • E307220103112 ()
  • E307220103110 ()
22010311

  • Patient examination/treatment drape, single-use

Monoart - E307220103100

Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: white
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103101 ()
  • E307220103102 ()
  • E307220103100 ()
22010310

  • Patient examination/treatment drape, single-use

Monoart - E307220103090

Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: light green
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103091 ()
  • E307220103092 ()
  • E307220103090 ()
22010309

  • Patient examination/treatment drape, single-use

Monoart - E307220103080

Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: light blue
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103081 ()
  • E307220103082 ()
  • E307220103080 ()
22010308

  • Patient examination/treatment drape, single-use

Monoart - E307220103070

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. Colour: pink
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103071 ()
  • E307220103072 ()
  • E307220103070 ()
22010307

  • Patient examination/treatment drape, single-use

Monoart - E307220103060

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. Colour: lilac
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103061 ()
  • E307220103062 ()
  • E307220103060 ()
22010306

  • Patient examination/treatment drape, single-use

Monoart - E307220103050

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. Colour: yellow
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103051 ()
  • E307220103052 ()
  • E307220103050 ()
22010305

  • Patient examination/treatment drape, single-use

Monoart - E307220103040

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. Colour: orange
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103041 ()
  • E307220103042 ()
  • E307220103040 ()
22010304

  • Patient examination/treatment drape, single-use

Monoart - E307220103030

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. Colour: blue
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103031 ()
  • E307220103032 ()
  • E307220103030 ()
22010303

  • Patient examination/treatment drape, single-use

Monoart - E307220103020

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. Colour: white
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103021 ()
  • E307220103022 ()
  • E307220103020 ()
22010302

  • Patient examination/treatment drape, single-use

Monoart - E307220103010

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. Colour: green.
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103010 ()
  • E307220103012 ()
  • E307220103011 ()
22010301

  • Patient examination/treatment drape, single-use

Monoart - E307220103000

Roll of 80 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 610 x 530 mm. Carton of 6 rolls. Colour: light blue
EURONDA SPA
MONOART APRON PG30
In Commercial Distribution

  • E307220103001 ()
  • E307220103002 ()
  • E307220103000 ()
22010300

  • Patient examination/treatment drape, single-use

Monoart - E307219101530

Roll of 100 patients aprons made from a waterproof polyethylene layer. The perforated tear-off parts make the aprons easy to use. The system with laces, allows to tie apron directly to the patient’s neck. Available in two sizes (120 and 160 cm respectively), these protect patients down to the knee or ankles. Carton of 6 rolls. Dimensions: 160 x 53 cm. Colour: blue.
EURONDA SPA
MONOART® APRON PG 20 XLong
In Commercial Distribution

  • E307219101530 ()
  • E307219101531 ()
  • E307219101532 ()
21910153

  • Patient examination/treatment drape, single-use

Monoart - E307219101510

Roll of 133 patients aprons made from a waterproof polyethylene layer. The perforated tear-off parts make the aprons easy to use. The system with laces, allows to tie apron directly to the patient’s neck. Available in two sizes (120 and 160 cm respectively), these protect patients down to the knee or ankles. Carton of 6 rolls. Dimensions: 120 x 53 cm. Colour: blue.
EURONDA SPA
MONOART® APRON PG 20 XLong
In Commercial Distribution

  • E307219101510 ()
  • E307219101511 ()
  • E307219101512 ()
21910151

  • Patient examination/treatment drape, single-use

Monoart - E307219101320

Roll of 200 patients aprons made from a waterproof polyethylene layer. Size 810x530 mm. Carton of 6 rolls. Colour: white
EURONDA SPA
MONOART APRON PG20
In Commercial Distribution

  • E307219101321 ()
  • E307219101322 ()
  • E307219101320 ()
21910132

  • Patient examination/treatment drape, single-use
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