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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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A.M.I. EasyDissect Disposable Tips Premium - EAMIEDI10310

No Description
AMI Agency for Medical Innovations GmbH
EDI1031
Not in Commercial Distribution

  • EAMIEDI10311 ()
  • EAMIEDI10310 ()

  • Outer Diameter: 5 Millimeter
  • Length: 44 Millimeter
EDI1031

  • Endoscopic electrosurgical electrode, monopolar, single-use

EasyClinch micro - EAMIECM10110

No Description
AMI Agency for Medical Innovations GmbH
ECM1011
Not in Commercial Distribution

  • EAMIECM10111 ()
  • EAMIECM10110 ()

  • Outer Diameter: 3 Millimeter
  • Length: 25 Millimeter
ECM1011

  • Endoscopic electrosurgical electrode, monopolar, single-use

A.M.I. EasyClinch Disposable Tips Premium - EAMIECI10310

No Description
AMI Agency for Medical Innovations GmbH
ECI1031
Not in Commercial Distribution

  • EAMIECI10311 ()
  • EAMIECI10310 ()

  • Outer Diameter: 5 Millimeter
  • Length: 44 Millimeter
ECI1031

  • Endoscopic electrosurgical electrode, monopolar, single-use

Comfort Drain - EAMICDS20010

The Comfort Drain is a flexible, silicone, elastic drain with knotless closure that facilitates drainage of perianal fistulas.
AMI Agency for Medical Innovations GmbH
CDS2001
In Commercial Distribution

  • EAMICDS20010 ()
  • EAMICDS20011 ()
CDS2001

  • Closed-wound drain, non-bioabsorbable

A.M.I.-dock TissueBag DLU Large - EAMIA102120

Loading unit for retrieving specimen for A.M.I.-dock Applicator 10mm. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
A10 212
Not in Commercial Distribution

  • EAMIA102120 ()
  • EAMIA102121 ()

  • Length: 180 Millimeter
A10 212

  • Tissue extraction bag

A.M.I.-dock TissueBag DLU - EAMIA102110

Loading unit for retrieving specimen for A.M.I.-dock Applicator 10mm. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
A10 211
Not in Commercial Distribution

  • EAMIA102110 ()
  • EAMIA102111 ()

  • Length: 180 Millimeter
A10 211

  • Tissue extraction bag

A.M.I.-dock Bluntdissect DLU 10mm - EAMIA101310

Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.
AMI Agency for Medical Innovations GmbH
A10 131
Not in Commercial Distribution

  • EAMIA101310 ()
  • EAMIA101311 ()

  • Length: 28 Millimeter
  • Outer Diameter: 8 Millimeter
A10 131

  • Dissection sponge

A.M.I.-dock Bluntdissect DLU 5mm - EAMIA052510

Loading unit for blunt dissection for A.M.I.-dock Applicator 5 mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR.
AMI Agency for Medical Innovations GmbH
A05 251
Not in Commercial Distribution

  • EAMIA052510 ()
  • EAMIA052511 ()

  • Length: 18 Millimeter
  • Outer Diameter: 4.5 Millimeter
A05 251

  • Dissection sponge

VenSure Nav Balloon Sinus Dilation System - EFIAE0135161

No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0135162 ()
  • EFIAE0135161 ()


  • Nasal/paranasal balloon catheter

VenSure Balloon Sinus Dilation System - EFIAE0135061

No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0135062 ()
  • EFIAE0135061 ()
E 01 3506

  • Nasal/paranasal balloon catheter

Tran Canula - EFABTC012

TranCanula is a single-use irrigation cannula for washing the anterior chamber of the eye, especially the trabecular meshwork and the iridocorneal angle following a cataract surgery. TranCanula is compatible with the Goniowash washing technique.
Fabrinal SA
TC01
In Commercial Distribution

  • EFABTC011 ()
  • EFABTC012 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

LuxaFlow® Ultra - EDMG2240050

Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syringes @ 1.5 g composite, Accessories. Color: B1
DMG Chemisch-Pharmazeutische Fabrik GmbH
224005
In Commercial Distribution

  • EDMG2240051 ()
  • EDMG2240050 ()
224005

  • Dental composite resin

LuxaFlow® Ultra - EDMG2240040

Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syringes @ 1.5 g composite, Accessories. Color: A3.5
DMG Chemisch-Pharmazeutische Fabrik GmbH
224004
In Commercial Distribution

  • EDMG2240041 ()
  • EDMG2240040 ()
224004

  • Dental composite resin

LuxaFlow® Ultra - EDMG2240030

Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syringes @ 1.5 g composite, Accessories. Color: A3
DMG Chemisch-Pharmazeutische Fabrik GmbH
224003
In Commercial Distribution

  • EDMG2240031 ()
  • EDMG2240030 ()
224003

  • Dental composite resin

LuxaFlow® Ultra - EDMG2240020

Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syringes @ 1.5 g composite, Accessories. Color: A2
DMG Chemisch-Pharmazeutische Fabrik GmbH
224002
In Commercial Distribution

  • EDMG2240021 ()
  • EDMG2240020 ()
224002

  • Dental composite resin

LuxaFlow® Ultra - EDMG2240010

Flowable light cure provisional add-on material. Esthetic add-ons and repairs. Content: 2 syringes @ 1,5 g composite, Accessories. Color: A1
DMG Chemisch-Pharmazeutische Fabrik GmbH
224001
In Commercial Distribution

  • EDMG2240011 ()
  • EDMG2240010 ()
224001

  • Dental composite resin

Ionosit Baseliner - EDMG2230020

Light-curing compomer base liner. Gap-free restorations. Content: 2 syringes @ 1.5 g paste, Accessories
DMG Chemisch-Pharmazeutische Fabrik GmbH
223002
In Commercial Distribution

  • EDMG2230021 ()
  • EDMG2230020 ()
223002

  • Dental composite resin

Ecosite Bond - EDMG2207580

Light-curing single component bonding agent. Quality fillings in no time. Content: 1 Bottle @ 5 ml of Ecosite Bond.
DMG Chemisch-Pharmazeutische Fabrik GmbH
220758
In Commercial Distribution

  • EDMG2207581 ()
  • EDMG2207580 ()
220758

  • Dentine bonding agent/set

Constic OW - EDMG2207050

Self-adhesive, light-curing,flowable composite. Do more with less. Content: 2 syringes @ 2g composite, Accessories. Color: Opaque-White
DMG Chemisch-Pharmazeutische Fabrik GmbH
220705
In Commercial Distribution

  • EDMG2207051 ()
  • EDMG2207050 ()
220705

  • Dental pit/fissure sealant
  • Dental composite resin

Constic B1 - EDMG2207040

Self-adhesive, light-curing,flowable composite. Do more with less. Content: 2 syringes @ 2g composite, Accessories. Color: B1
DMG Chemisch-Pharmazeutische Fabrik GmbH
220704
In Commercial Distribution

  • EDMG2207041 ()
  • EDMG2207040 ()
220704

  • Dental pit/fissure sealant
  • Dental composite resin
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