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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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
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927FA00112 ()
  • B927FA00111 ()
  • B927FA00110 ()


  • Surgical/medical face mask, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292802 ()
  • B927200292801 ()
  • B927200292800 ()
20029280

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292792 ()
  • B927200292791 ()
  • B927200292790 ()
20029279

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292782 ()
  • B927200292781 ()
  • B927200292780 ()
20029278

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292772 ()
  • B927200292771 ()
  • B927200292770 ()
20029277

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292762 ()
  • B927200292761 ()
  • B927200292760 ()
20029276

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292752 ()
  • B927200292751 ()
  • B927200292750 ()
20029275

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292742 ()
  • B927200292741 ()
  • B927200292740 ()
20029274

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292732 ()
  • B927200292731 ()
  • B927200292730 ()
20029273

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292720 ()
  • B927200292721 ()
20029272

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292710 ()
  • B927200292711 ()
20029271

  • Surgical/medical face mask, non-antimicrobial, single-use
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927200292702 ()
  • B927200292701 ()
  • B927200292700 ()
20029270

  • Surgical/medical face mask, non-antimicrobial, single-use
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