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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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AincA - B005002470

Adapter, Mask Elbow, w/Adjustable Pop-Off Valve (Large), 22mmM x 22mmM/15mmF, Aluminum
ANESTHESIA ASSOCIATES, INC.
00-247
In Commercial Distribution

  • B005002470 ()
00-247

  • Mechanical expiratory valve, reusable

Ceramage - E23519460

Ceramage F-Gum-Br
SHOFU DENTAL CORPORATION
1946
In Commercial Distribution

  • E23519460 ()
1946

  • Dental prosthesis veneer resin

Amaris Flow - E22119461

The ideal addition to Amaris. Simple modelling of the incisal edge. Easy wetting. Fine canullae allows to apply small amounts.
VOCO GmbH
1946
In Commercial Distribution

  • E22119461 ()
1946

  • Dental composite resin

Arthrex® - 00888867041509

2-0 FIBERSTICK, 2-0 FIBERWIRE
ARTHREX, INC.
AR-7222
In Commercial Distribution

  • 00888867041509 ()
  • M150AR72222 ()
  • 10888867041506 ()
AR-7222

  • Polyolefin/fluoropolymer suture, multifilament

BISICO Cem DC A3 - EBIB752401

Double-curing, fine-flowing micro-hybrid composite material for permanent attachment of crowns, bridges, inlays and endodontic posts made of carbon fibers and glass fibers. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75240
In Commercial Distribution

  • EBIB752401 ()
75240

  • Dental composite resin

BISICO Repo-Core DC A3 25ml - EBIB752201

Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75220
In Commercial Distribution

  • EBIB752201 ()
75220

  • Dental composite resin

BISICO Repo-Core DC A3 Mini - EBIB752001

Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75200
In Commercial Distribution

  • EBIB752001 ()
75200

  • Dental composite resin

BISICO Cementime DC - EBIB037301

Dual-curing, semipermanent luting cement for crowns and bridges on dental implants
bisico Bielefelder Dentalsilicone GmbH & Co. KG
03730
In Commercial Distribution

  • EBIB037301 ()
03730

  • Ethoxy benzoic acid dental cement

Acrylic Spheres 20 mm, 3.6 cc - 10697660000357

Acrylic spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-320
Not in Commercial Distribution


  • Outer Diameter: 20 Millimeter
  • Total Volume: 3.6 Milliliter


  • Orbital sphere implant

Silicone Spheres (20 mm, 4.2 cc) - 10697660000258

Silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-220
Not in Commercial Distribution


  • Total Volume: 4.2 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant
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