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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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ROEKO GuttaFlow®2 - E165600137020

The ROEKO GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips + Stops (20 pcs), 1 x Adapters for RotoMix™ (3 pcs), 1 x Dispenser, 1 x ROEKO Guttapercha points Top Color ISO 15-40 (100 pcs) and 1 x ROEKO Guttapercha points Greater Taper 0.04 20-45 (60 pcs).
Coltène/Whaledent GmbH + Co. KG
INTROKIT
In Commercial Distribution

  • E165600137020 ()
60013702

  • Endodontic filling/sealing material

ROEKO GuttaFlow®2 - E165600137010

No Description
Coltène/Whaledent GmbH + Co. KG
STANDARD SET
In Commercial Distribution

  • E165600137010 ()
60013701

  • Endodontic filling/sealing material

ROEKO RoekoSeal Single Dose - E16555430

No Description
Coltène/Whaledent GmbH + Co. KG
SAMPLE
In Commercial Distribution

  • E16555430 ()
5543

  • Endodontic filling/sealing material

ROEKO RoekoSeal Single Dose - E1653491030

No Description
Coltène/Whaledent GmbH + Co. KG
349103
In Commercial Distribution

  • E1653491030 ()
349103

  • Endodontic filling/sealing material

ROEKO RoekoSeal Automix - E1653491020

No Description
Coltène/Whaledent GmbH + Co. KG
Refill pack Dual-barrel syringe
In Commercial Distribution

  • E1653491020 ()
349102

  • Endodontic filling/sealing material

ROEKO RoekoSeal Automix - E1653491000

No Description
Coltène/Whaledent GmbH + Co. KG
Set
In Commercial Distribution

  • E1653491000 ()
349100

  • Endodontic filling/sealing material

CaviCide - 00615375005361

Surface Disinfectant Decontaminant Cleaner
METREX RESEARCH, LLC
13-1024
In Commercial Distribution

  • H97113102422 ()
  • 00615375005361 ()
  • 10615375005368 ()

  • Total Volume: 24 Fluid Ounce


  • Medical device disinfection agent

Envirocide - 00615375005354

Surface Disinfectant Decontaminant Cleaner
METREX RESEARCH, LLC
13-3324
In Commercial Distribution

  • H97113332427 ()
  • 00615375005354 ()

  • Total Volume: 24 Fluid Ounce


  • Medical device disinfection agent

CaviCide1 - 00615375005415

1 Minute 1 Step Germicidal Spray Fragrance Free
METREX RESEARCH, LLC
13-5024
In Commercial Distribution

  • H97113502426 ()
  • 00615375005415 ()

  • Total Volume: 24 Fluid Ounce


  • Medical device disinfection agent

Symblepharon Ring Conformer Large, In Bulk - M87221416V95

The Symblepharon rings are used to prevent retraction of the conjunctiva cul-de-sac. The ring is inserted between the eye and the lid and is supported by the sclera without touching the cornea. The purpose of the Symblepharon Rings is to avoid tissue adhesion after excision of the symblepharon. The ring has a center hole to enable the patient to see. The surfaces are polished in order to avoid any abrasion of the cornea or ocular globe. The Symblepharon Rings are medical devices made of acrylic (PMMA). They must not be autoclaved, otherwise they will be damaged: ethylene oxide sterilization is recommended. The devices' family has different sizes (small, medium, large).
Oculo-Plastik Inc
21-416V
Not in Commercial Distribution

  • M87221416V95 ()

  • Outer Diameter: 24 Millimeter


  • Symblepharon ring, synthetic
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