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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Disposable, hypo-allergenic face mask with 3 layers: • Soft, coloured and water-repellent non-woven fabric for improved protection against dust and humidity; • PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency) filter; • Comfortable non-woven cotton lining for extra absorbance of sweat and humidity. It is ideal for protection from dust and aerosols in accordance with the EN 14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Box of 50 masks Colour: Pink
EURONDA SPA
Monoart Face Mask Protection 3
In Commercial Distribution

  • E3072171170 ()
  • E3072171171 ()
  • E3072171172 ()
217117

  • Surgical/medical face mask, non-antimicrobial, single-use
Disposable, hypo-allergenic face mask with 3 layers: • Soft, coloured and water-repellent non-woven fabric for improved protection against dust and humidity; • PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency) filter; • Comfortable non-woven cotton lining for extra absorbance of sweat and humidity. It is ideal for protection from dust and aerosols in accordance with the EN 14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Box of 50 masks Colour: Yellow
EURONDA SPA
Monoart Face Mask Protection 3
In Commercial Distribution

  • E3072171160 ()
  • E3072171161 ()
  • E3072171162 ()
217116

  • Surgical/medical face mask, non-antimicrobial, single-use
Disposable, hypo-allergenic face mask with 3 layers: • Soft, coloured and water-repellent non-woven fabric for improved protection against dust and humidity; • PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency); • Comfortable non-woven cotton lining for extra absorbance of sweat and humidity. It is ideal for protection from dust and aerosols in accordance with the EN 14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Box of 50 masks Color: Orange
EURONDA SPA
Monoart Face Mask Protection 3
In Commercial Distribution

  • E3072171150 ()
  • E3072171151 ()
  • E3072171152 ()
217115

  • Surgical/medical face mask, non-antimicrobial, single-use
Disposable, hypo-allergenic face mask with 3 layers: • Soft, coloured and water-repellent non-woven fabric for improved protection against dust and humidity; • PFE (Particle Filtration Efficiency) filter and BFE (Bacterial Filtration Efficiency) filter; • Comfortable non-woven cotton lining for extra absorbance of sweat and humidity. It is ideal for protection from dust and aerosols in accordance with the EN 14683 standard (differential pressure: surgical mask breathability rating). Built-in nose bridge. Box of 50 masks. Color: green
EURONDA SPA
Monoart Face Mask Protection 3
In Commercial Distribution

  • E3072171140 ()
  • E3072171141 ()
  • E3072171142 ()
217114

  • Surgical/medical face mask, non-antimicrobial, single-use
Disposable, hypo-allergenic face mask with 3 layer: water-repellent non-woven fabric for improved protection against dust and humidity. Box of 50 masks. Carton of 20 boxes. Colour: light blue.
EURONDA SPA
Monoart Face Mask Protection 3
In Commercial Distribution

  • E3072171120 ()
  • E3072171121 ()
  • E3072171122 ()
217112

  • Surgical/medical face mask, non-antimicrobial, single-use
Graffiti patterned disposable medical face masks, fluid resistant, ideal for aerosol and splash protection. Prevent airborne transmission of microorganisms and ensure excellent breathability, which exceeds the requirements of EN 14683. Equipped with an XTrap filter that captures bacteria and viruses for three times more protection and a particulate and antibacterial filter (99.8% filtration efficiency). Provided with comfortable rounded elastic bands and an elongated nose bridge with a double track for maximum stability. Box of 50 masks. Colour: lilac with pattern
EURONDA SPA
Monoart Face Mask Protection Graffiti
In Commercial Distribution

  • E3072170151 ()
  • E3072170150 ()
  • E3072170152 ()
217015

  • Surgical/medical face mask, non-antimicrobial, single-use
Graffiti patterned disposable medical face masks, fluid resistant, ideal for aerosol and splash protection. Prevent airborne transmission of microorganisms and ensure excellent breathability, which exceeds the requirements of EN 14683. Equipped with an XTrap filter that captures bacteria and viruses for three times more protection and a particulate and antibacterial filter (99.8% filtration efficiency). Provided with comfortable rounded elastic bands and an elongated nose bridge with a double track for maximum stability. Box of 50 masks. Colour: pink with pattern
EURONDA SPA
Monoart Face Mask Protection Graffiti
In Commercial Distribution

  • E3072170141 ()
  • E3072170140 ()
  • E3072170142 ()
217014

  • Surgical/medical face mask, non-antimicrobial, single-use
Graffiti patterned disposable medical face masks, fluid resistant, ideal for aerosol and splash protection. Prevent airborne transmission of microorganisms and ensure excellent breathability, which exceeds the requirements of EN 14683. Equipped with an XTrap filter that captures bacteria and viruses for three times more protection and a particulate and antibacterial filter (99.8% filtration efficiency). Provided with comfortable rounded elastic bands and an elongated nose bridge with a double track for maximum stability. Box of 50 masks. Colour: lime with pattern
EURONDA SPA
Monoart Face Mask Protection Graffiti
In Commercial Distribution

  • E3072170131 ()
  • E3072170130 ()
  • E3072170132 ()
217013

  • Surgical/medical face mask, non-antimicrobial, single-use
Graffiti patterned disposable medical face masks, fluid resistant, ideal for aerosol and splash protection. Prevent airborne transmission of microorganisms and ensure excellent breathability, which exceeds the requirements of EN 14683. Equipped with an XTrap filter that captures bacteria and viruses for three times more protection and a particulate and antibacterial filter (99.8% filtration efficiency). Provided with comfortable rounded elastic bands and an elongated nose bridge with a double track for maximum stability. Box of 50 masks. Colour: Light blue with pattern
EURONDA SPA
Monoart Face Mask Protection Graffiti
In Commercial Distribution

  • E3072170121 ()
  • E3072170120 ()
  • E3072170122 ()
217012

  • Surgical/medical face mask, non-antimicrobial, single-use
Disposable earloop face mask with 4 layers: two outer layers of hydrophobic PP spunbond, PP sub micron meltblown filter layer, inner layer of hydrophilic PP spunbond. Built-in nose bridge. Latex free. Application: for medical personnel and paramedics to ensure patient protection from microbial agents. Box of 50 masks. Colour: Aquamarine.
EURONDA SPA
Monoart Face Mask Protection Soft
In Commercial Distribution

  • E3072170111 ()
  • E3072170110 ()
  • E3072170112 ()
217011

  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - YELLOW
OMNIA SRL
30.M1304.00
In Commercial Distribution

  • 08056646503216 ()
  • 08056646503209 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH SPLASHGUARD VISOR AND ELASTIC BANDS - LIGHT BLUE
OMNIA SRL
30.M1221.00
In Commercial Distribution

  • 08056646501441 ()
  • 08056646501434 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - PURPLE
OMNIA SRL
30.M1309.00
In Commercial Distribution

  • 08056646501427 ()
  • 08056646501410 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - ORANGE
OMNIA SRL
30.M1308.00
In Commercial Distribution

  • 08056646501403 ()
  • 08056646501397 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - WITH PRINTING
OMNIA SRL
30.M1307.00
In Commercial Distribution

  • 08056646501380 ()
  • 08056646501373 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH STRINGS - LIGHT GREEN
OMNIA SRL
30.M1305.00
In Commercial Distribution

  • 08056646501366 ()
  • 08056646501359 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH STRINGS - LIGHT BLUE
OMNIA SRL
30.M1303.00
In Commercial Distribution

  • 08056646501342 ()
  • 08056646501335 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - BLUE
OMNIA SRL
30.M1302.00
In Commercial Distribution

  • 08056646501328 ()
  • 08056646501311 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - GREEN
OMNIA SRL
30.M1301.00
In Commercial Distribution

  • 08056646501298 ()
  • 08056646501304 ()


  • Surgical/medical face mask, non-antimicrobial, single-use
The sterile "Procedural Packages for Diagnosis and Surgery" are intended for use by specialized personnel and are composed of consumables and devices intended for the preparation of the operating field, maintenance of cleanliness (ensuring the hygiene of the field and limiting the risk of contamination) and the performance of various types of surgery. The devices provided can be: - non-invasive devices, for the preparation of the operating field - for example: drapes, gowns, masks and accessories (bandages, sheaths, tool pockets, bags for collecting liquids, fixed pliers for drapes, etc.) - invasive surgical devices for temporary use not in contact with the central circulatory system and with the nervous system - for example: needles and syringes with needle, disposable scalpels and gauze. - devices for channeling liquids intended for irrigation. Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model number : X = alphabetic character YYYY=n° of 4 number character.
OMNIA SRL
12.XYYYY.00
In Commercial Distribution

  • 08056646500840 ()


  • General surgical procedure kit, non-medicated, single-use
Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. Surgical Procedure Packs may be packages as a combination of any of the following components: - Surgical gowns (various models) with or without hand towels - Surgical Drapes: - Mayo drape - Absorbent/liquid proof drapes (with or without adhesive) - Adhesive side drape - Liquid repellent drape with or without adhesive - Face mask - Protective caps - Sheath/tubing sleeve - Surgical aspirator with adaptor - Surgical gauze - Disinfection sponge and/or basin - Adhesive films - Syringe - Needles - Single-use scalpel - Small dental mirror/dental explorer/tweezer - Irrigation/infusion line - Stopcock and ramp for infusion - Waste bag for contaminated material - Bone collector - Saliva ejector - Basin - Medical paper Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model Number: X = alphabetic character YYYY= n° of 4 number character
OMNIA SRL
12.XYYYY.00
In Commercial Distribution

  • 8056646500239 ()
  • 08056646500222 ()
  • 8056646500246 ()
  • 8056646500352 ()
  • 8056646500253 ()
  • 8056646500260 ()
  • 8056646500277 ()
  • 8056646500284 ()
  • 8056646500291 ()
  • 8056646500307 ()
  • 8056646500314 ()
  • 8056646500321 ()
  • 8056646500338 ()
  • 8056646500345 ()
  • 8056646500437 ()
  • 8056646500420 ()
  • 8056646500413 ()
  • 8056646500406 ()
  • 8056646500390 ()
  • 8056646500383 ()
  • 8056646500376 ()
  • 8056646500369 ()
  • 8056646500451 ()
  • 8056646500444 ()
  • 8056646500475 ()
  • 8056646500468 ()
  • 80566465000505 ()
  • 805664650505 ()
  • 8056646500505 ()
  • 8056646500512 ()
  • 08056646500529 ()
  • 08056646500536 ()
  • 08056646500543 ()
  • 08056646500550 ()
  • 08056646500567 ()
  • 08056646500581 ()
  • 08056646500635 ()
  • 08056646500628 ()
  • 08056646500611 ()
  • 08056646500574 ()
  • 08056646500604 ()
  • 08056646500598 ()
  • 08056646500659 ()
  • 08056646500666 ()
  • 08056646500642 ()
  • 08056646500673 ()
  • 08056646500680 ()
  • 08056646500697 ()
  • 08056646500826 ()
  • 08056646500819 ()
  • 08056646500802 ()
  • 08056646500796 ()
  • 08056646500789 ()
  • 08056646500772 ()
  • 08056646500765 ()
  • 08056646500758 ()
  • 08056646500734 ()
  • 08056646500727 ()
  • 08056646500710 ()
  • 08056646500703 ()


  • General surgical procedure kit, non-medicated, single-use
Mask Surgical Face PRIMAGARD80 Tie Light And Cool Blue Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-2321
In Commercial Distribution

  • 50885632135840 ()
  • 10885632135842 ()
  • 60885632135847 ()


  • Surgical/medical face mask, single-use
Mask Primagard160 Surgical Face Tie Plume Protector Anti-fog Foam Not Made With Natural Rubber Latex Gray MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-6403
In Commercial Distribution

  • 50885632134577 ()
  • 10885632134579 ()
  • 60885632134574 ()


  • Surgical/medical face mask, single-use
Mask Primagard160 Procedure Face Anti-fog Foam Anti Glare Strip Stretchy Earloop W/ Visor Foam Strip Aluminum Nose Piece Not Made With Natural Rubber Latex Indigo Disposable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-1563
In Commercial Distribution

  • 50885632134546 ()
  • 10885632134548 ()
  • 60885632134543 ()


  • Eye splash shield, single-use
MediChoice Face Mask Surgical Tie Primasoft 160 White (Case Of 300)
OWENS & MINOR DISTRIBUTION, INC.
PG4-2333
In Commercial Distribution

  • 50885632123083 ()
  • 10885632123085 ()
  • 60885632123080 ()


  • Surgical/medical face mask, single-use
Mask Surgical PRIMAGARD160 Anti-Fog Foam With Tie Aluminum Nose Piece Indigo Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-4073
In Commercial Distribution

  • 50885632100701 ()
  • 10885632100703 ()
  • 60885632100708 ()


  • Surgical/medical face mask, single-use
Mask Surgical PRIMAGARD80 Anti-Fog Foam With Tie Aluminum Nose Piece Denim Blue Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-4021
In Commercial Distribution

  • 50885632100688 ()
  • 10885632100680 ()
  • 60885632100685 ()


  • Surgical/medical face mask, single-use
Mask Surgical Face PRIMAGARD80 Tie Soft Bill Blue Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-2121
In Commercial Distribution

  • 50885632100619 ()
  • 10885632100611 ()
  • 60885632100616 ()


  • Surgical/medical face mask, single-use
Mask Surgical Face PRIMAGARD80 Tie Blue Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-2001
In Commercial Distribution

  • 50885632100589 ()
  • 10885632100581 ()
  • 60885632100586 ()


  • Surgical/medical face mask, single-use
Mask Procedure Face PRIMAGARD160 Anti-Fog Foam Anti Glare Strip Stretchy Earloop With Anti Glare Visor Foam Strip Aluminum Nose Piece Indigo Disposable Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-1573
In Commercial Distribution

  • 50885632100541 ()
  • 10885632100543 ()
  • 60885632100548 ()


  • Eye splash shield, single-use
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