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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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Green gown with cuffs (length 120 cm) - 08056646507153

Green gown with cuffs (length 120 cm)
OMNIA SRL
30.D1006.00
In Commercial Distribution

  • 08056646507160 ()
  • 08056646507153 ()


  • Surgical gown, single-use

Green gown with elastics (length 120 cm) - 08056646507139

Green gown with elastics (length 120 cm)
OMNIA SRL
30.D1004.00
In Commercial Distribution

  • 08056646507146 ()
  • 08056646507139 ()


  • Surgical gown, single-use

Omnitex C - 08056646506705

Conical sheath Omnitex C - white - nitrile
OMNIA SRL
30.Z0131.00
In Commercial Distribution

  • 08056646506712 ()
  • 08056646506705 ()


  • Medical equipment/instrument drape, single-use

Omnitex U - 08056646506286

Universal sheath Omnitex U - green - nitrile
OMNIA SRL
30.Z0010.00
In Commercial Distribution

  • 08056646506293 ()
  • 08056646506286 ()


  • Medical equipment/instrument drape, single-use

Universal seat cover and backrest cover Shell Cover - 08056646505883

Universal seat cover and backrest cover Shell Cover
OMNIA SRL
20.O0105.00
In Commercial Distribution

  • 08056646505890 ()
  • 08056646505883 ()


  • Medical equipment/instrument drape, single-use

Omnicover - 08056646505722

Round waterproof headrest cover Ø 22 cm with elastic Shell Cover
OMNIA SRL
20.O0010.00
In Commercial Distribution

  • 08056646505739 ()
  • 08056646505722 ()


  • Medical equipment/instrument drape, single-use

Irrigation line, Bien Air - 08056646504947

Tube set sterile S600 (10/pkg)
OMNIA SRL
32.F0241.00
In Commercial Distribution

  • 08056646504930 ()
  • 08056646504947 ()


  • Disposable surgical irrigation/aspiration system

Manual irrigation line, Nobel - 08056646504923

Omnirrigator (5/pkg)
OMNIA SRL
32.F1004.00
In Commercial Distribution

  • 08056646504916 ()
  • 08056646504923 ()


  • Disposable surgical irrigation/aspiration system

Irrigation line, Nobel - 08056646504909

Hose set for machinery (10/pkg)
OMNIA SRL
32.F0128.00
In Commercial Distribution

  • 08056646504893 ()
  • 08056646504909 ()


  • Disposable surgical irrigation/aspiration system

Punches, NOBEL - 08056646504879

Guided Soft Tissue Punch 6.0/WP 5/pkg
OMNIA SRL
32.Z2008.00
In Commercial Distribution

  • 08056646504862 ()
  • 08056646504879 ()


  • Dental soft-tissue coring punch, single-use

Punches, NOBEL - 08056646504855

Guided Soft Tissue Punch RP 5/pkg
OMNIA SRL
32.Z2007.00
In Commercial Distribution

  • 08056646504848 ()
  • 08056646504855 ()


  • Dental soft-tissue coring punch, single-use

Punches, NOBEL - 08056646504831

Guided Soft Tissue Punch NP 5/pkg
OMNIA SRL
32.Z2006.00
In Commercial Distribution

  • 08056646504824 ()
  • 08056646504831 ()


  • Dental soft-tissue coring punch, single-use

Punches, NOBEL - 08056646504817

Soft Tissue Punch Ø 6.2 mm, 5-pack
OMNIA SRL
32.Z2004.00
In Commercial Distribution

  • 08056646504800 ()
  • 08056646504817 ()


  • Dental soft-tissue coring punch, single-use

Punches, NOBEL - 08056646504794

Soft Tissue Punch Ø 5.2 mm, 5-pack
OMNIA SRL
32.Z2002.00
In Commercial Distribution

  • 08056646504787 ()
  • 08056646504794 ()


  • Dental soft-tissue coring punch, single-use

Punches, NOBEL - 08056646504770

Soft Tissue Punch Ø 4.1 mm, 5-pack
OMNIA SRL
32.Z2000.00
In Commercial Distribution

  • 08056646504763 ()
  • 08056646504770 ()


  • Dental soft-tissue coring punch, single-use

Adhesive film - 08056646503919

STERILE PROTECT. FILM (10/pkg) - Bien Air
OMNIA SRL
32.U0026.00
In Commercial Distribution

  • 08056646503902 ()
  • 08056646503919 ()


  • Medical equipment/instrument drape, single-use

Infusion Sets, Bien Air - 08056646503896

Irrigation Line KM (10/pkg)
OMNIA SRL
32.F0284.00
In Commercial Distribution

  • 08056646503889 ()
  • 08056646503896 ()


  • Disposable surgical irrigation/aspiration system

Infusion Sets, Bien Air - 08056646503872

Irrigation Line (10/pkg)
OMNIA SRL
32.F0260.00
In Commercial Distribution

  • 08056646503865 ()
  • 08056646503872 ()


  • Disposable surgical irrigation/aspiration system

FACE MASKS - 08056646503216

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

Sterile PTFE Surgical Suture - 08056646503193

PTFE Suture 60 cm - 5/0 - Extra Cutting tip - 12 mm Needle 3/8 - Body Reverse Cutting
OMNIA SRL
32.Z4409.00
In Commercial Distribution

  • 08056646503193 ()
  • 08056646503186 ()


  • Polyolefin/fluoropolymer suture, monofilament
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