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 - 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
Mask Surgical PRIMASOFT80 For Sensitive Skin Anti-Fog Foam With Tie Aluminum Nose Piece White Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-4331
In Commercial Distribution

  • 50885632100206 ()
  • 10885632100208 ()
  • 60885632100203 ()


  • Surgical/medical face mask, single-use
Mask Surgical Face PRIMAGARD80 Tie Soft Bill Green Large Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-2161
In Commercial Distribution

  • 50885632135857 ()
  • 10885632135859 ()
  • 60885632135854 ()


  • Surgical/medical face mask, single-use
Mask Surgical Face Primagard160 Tie Soft Bill Not Made With Natural Rubber Latex Large White MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-3363
In Commercial Distribution

  • 50885632135833 ()
  • 10885632135835 ()
  • 60885632135830 ()


  • Surgical/medical face mask, single-use
Mask Primagard160 Surgical Face Anti-fog Foam Anti Glare Strip With Visor Tie Aluminum Nose Piece Not Made With Natural Rubber Latex Blue MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-5063
In Commercial Distribution

  • 50885632134560 ()
  • 10885632134562 ()
  • 60885632134567 ()


  • Eye splash shield, single-use
Mask Primagard80 Surgical Face W/ Horizontal Tie Not Made With Natural Rubber Latex Blue MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-2561
In Commercial Distribution

  • 50885632134553 ()
  • 10885632134555 ()
  • 60885632134550 ()


  • Surgical/medical face mask, single-use
Mask Primagard80 Procedure Face Not Made With Natural Rubber Latex Non Sterile Blue MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-1211
In Commercial Distribution

  • 50885632134539 ()
  • 10885632134531 ()
  • 60885632134536 ()


  • Surgical/medical face mask, single-use
Surgical Face Mask Tie Primasoft 160 Anti Fog Foam With Alumin Not Made With Natural Rubber Latex Blue Latex Free MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-5073
In Commercial Distribution

  • 50885632100749 ()
  • 10885632100741 ()
  • 60885632100746 ()
  • 20885632100748 ()


  • Eye splash shield, single-use
Mask Surgical Face PRIMASOFT160 For Sensitive Skin Anti-Fog Foam Anti Glare Strip With Anti Glare Visor Tie Aluminum Nose Piece White Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-5033
In Commercial Distribution

  • 50885632100732 ()
  • 10885632100734 ()
  • 60885632100739 ()


  • Eye splash shield, single-use
Mask Surgical PRIMAGARD80 Anti-Fog Film With Tie Aluminum Nose Piece Green Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-4241
In Commercial Distribution

  • 50885632100718 ()
  • 10885632100710 ()
  • 60885632100715 ()


  • Surgical/medical face mask, single-use
Mask Surgical Face PRIMAGARD80 Tie With Adhesive Strip Green Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-4051
In Commercial Distribution

  • 50885632100695 ()
  • 10885632100697 ()
  • 60885632100692 ()


  • Surgical/medical face mask, single-use
Mask Surgical Face PRIMASOFT80 For Sensitive Skin Tie White Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-2331
In Commercial Distribution

  • 50885632100633 ()
  • 10885632100635 ()
  • 60885632100630 ()


  • Surgical/medical face mask, single-use
Mask Surgical Face PRIMAGARD160 Tie Indigo Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-2073
In Commercial Distribution

  • 50885632100596 ()
  • 10885632100598 ()
  • 60885632100593 ()


  • Surgical/medical face mask, single-use
Mask Procedure Face PRIMASOFT80 For Sensitive Skin White Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-1331
In Commercial Distribution

  • 50885632100534 ()
  • 10885632100536 ()
  • 60885632100531 ()


  • Surgical/medical face mask, single-use
Mask Procedure Face PRIMAGARD120 Denim Blue Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-1092
In Commercial Distribution

  • 50885632100510 ()
  • 10885632100512 ()
  • 60885632100517 ()


  • Surgical/medical face mask, single-use
Mask Procedure Face PRIMAGARD160 With Anti-Fog Foam Indigo Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-1073
In Commercial Distribution

  • 50885632100503 ()
  • 10885632100505 ()
  • 60885632100500 ()


  • Surgical/medical face mask, single-use
Mask Procedure Face PRIMAGARD80 Isolation With Earloop Yellow Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
PG4-1001
In Commercial Distribution

  • 50885632100480 ()
  • 10885632100482 ()
  • 60885632100487 ()


  • Surgical/medical face mask, single-use
Optima Ear Loop Procedural Masks Pink
Keystone Industries
1018610
Not in Commercial Distribution

  • H66810186101 ()
  • H66810186100 ()
1018610

  • Surgical/medical face mask, non-antimicrobial, single-use
Surgical Tie-On Masks Blue
Keystone Industries
1018510
Not in Commercial Distribution

  • H66810185101 ()
  • H66810185100 ()
1018510

  • Surgical/medical face mask, non-antimicrobial, single-use
Optima Ear Loop Procedural Masks Green
Keystone Industries
1018410
Not in Commercial Distribution

  • H66810184101 ()
  • H66810184100 ()
1018410

  • Surgical/medical face mask, non-antimicrobial, single-use
Procedural Ear Loop Masks Green
Keystone Industries
1018210
Not in Commercial Distribution

  • H66810182101 ()
  • H66810182100 ()
1018210

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