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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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Medium 10-20 Single-Use Strip Kit (Qty 5)
ADVANCED BRAIN MONITORING, INC.
XS30-4212.5
In Commercial Distribution

  • 00850015266331 ()


  • Patient monitoring system module, electroencephalographic
Small 10-20 Single-Use Strip Kit (Qty 5)
ADVANCED BRAIN MONITORING, INC.
XS30-4211.5
In Commercial Distribution

  • 00850015266324 ()


  • Patient monitoring system module, electroencephalographic
Medium 10-20 Single-Use Strip Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4212
In Commercial Distribution

  • 00850015266317 ()


  • Patient monitoring system module, electroencephalographic
Small 10-20 Single-Use Strip Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4211
In Commercial Distribution

  • 00850015266300 ()


  • Patient monitoring system module, electroencephalographic
X24 Disposable Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS24-4321
In Commercial Distribution

  • 00851113007895 ()


  • Analytical scalp electrode, single-use
X10 Disposable Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS10-4321
In Commercial Distribution

  • 00851113007888 ()


  • Analytical scalp electrode, single-use
Synapse Cream Kit
ADVANCED BRAIN MONITORING, INC.
XS02-4351
In Commercial Distribution

  • 00851113007451 ()


  • Electrode conductive medium
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
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
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
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
Quantikine Erythropoietin Control 3 (10 vials)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
CEP03
In Commercial Distribution

  • 10815762021685 ()
  • 00815762021688 ()
CEP03

  • Erythropoietin (EPO) IVD, control
Quantikine Erythropoietin Control 1 & 2 (5 vials of each)
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
CEP01
In Commercial Distribution

  • 00815762021671 ()
CEP01

  • Erythropoietin (EPO) IVD, control
ARCHITECT Folate Calibrators
ABBOTT IRELAND
1P74-02
In Commercial Distribution

  • 00380740002091 ()
01P7402

  • Folate (vitamin B9) IVD, calibrator
BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-20
In Commercial Distribution

  • 00850018568180 ()

  • Total Volume: 20 Milliliter
ABS-3000-20

  • Bone matrix implant, synthetic, non-antimicrobial
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 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
Acrylic and 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 users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-320
Not in Commercial Distribution

  • M8721132001 ()

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


  • Orbital sphere implant
Acrylic and 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 users must gas sterilize (EtO) the acrylic spheres (not autoclave). 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

  • M8721122000 ()

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


  • Orbital sphere implant
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
ⅥW-B012注吹球
In Commercial Distribution

  • 06924274950554 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
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