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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Size: Pediatric 8 mm; Type: Radiopaque
Boston Medical Products, Inc.
32008R
In Commercial Distribution

  • EBES32008R0 ()
  • EBES32008R1 ()

  • Angle (Upper Limb to Outer Limb): 70 degrees
  • Length (Outer Limb): 45 mm
  • Outer Diameter (Outer Limb): 8 mm
  • Length (Lower Inner Limb): 42 mm
  • Length (Upper Inner Limb): 46 mm
  • Length (Inner Limb): 96 mm
  • Outer Diameter (Inner Limb): 8 mm
32008R

  • Trachea prosthesis
Size: Pediatric 7 mm; Type: Radiopaque
Boston Medical Products, Inc.
32007R
In Commercial Distribution

  • EBES32007R0 ()
  • EBES32007R1 ()

  • Angle (Upper Limb to Outer Limb): 70 degrees
  • Length (Outer Limb): 45 mm
  • Outer Diameter (Outer Limb): 6 mm
  • Length (Lower Inner Limb): 43 mm
  • Length (Upper Inner Limb): 46 mm
  • Length (Inner Limb): 95 mm
  • Outer Diameter (Inner Limb): 7 mm
32007R

  • Trachea prosthesis
Size: Pediatric 6 mm; Type: Radiopaque
Boston Medical Products, Inc.
32006R
In Commercial Distribution

  • EBES32006R0 ()
  • EBES32006R1 ()

  • Angle (Upper Limb to Outer Limb): 70 degrees
  • Length (Outer Limb): 45 mm
  • Outer Diameter (Outer Limb): 6 mm
  • Length (Lower Inner Limb): 42 mm
  • Length (Upper Inner Limb): 46 mm
  • Length (Inner Limb): 94 mm
  • Outer Diameter (Inner Limb): 6 mm
32006R

  • Trachea prosthesis
Size: Pediatric 9 mm; Type: Clear
Boston Medical Products, Inc.
320009
In Commercial Distribution

  • EBES3200090 ()
  • EBES3200091 ()

  • Angle (Upper Limb to Outer Limb): 70 degrees
  • Length (Outer Limb): 45 mm
  • Outer Diameter (Outer Limb): 8 mm
  • Length (Lower Inner Limb): 43 mm
  • Length (Upper Inner Limb): 46 mm
  • Length (Inner Limb): 97 mm
  • Outer Diameter (Inner Limb): 9 mm
320009

  • Trachea prosthesis
Size: Pediatric 7 mm; Type: Clear
Boston Medical Products, Inc.
320007
In Commercial Distribution

  • EBES3200070 ()
  • EBES3200071 ()

  • Angle (Upper Limb to Outer Limb): 70 degrees
  • Length (Outer Limb): 45 mm
  • Outer Diameter (Outer Limb): 6 mm
  • Length (Lower Inner Limb): 43 mm
  • Length (Upper Inner Limb): 46 mm
  • Length (Inner Limb): 95 mm
  • Outer Diameter (Inner Limb): 7 mm
320007

  • Trachea prosthesis
Size: Pediatric 6 mm; Type: Clear
Boston Medical Products, Inc.
320006
In Commercial Distribution

  • EBES3200060 ()
  • EBES3200061 ()

  • Angle (Upper Limb to Outer Limb): 70 degrees
  • Length (Outer Limb): 45 mm
  • Outer Diameter (Outer Limb): 6 mm
  • Length (Lower Inner Limb): 42 mm
  • Length (Upper Inner Limb): 46 mm
  • Length (Inner Limb): 94 mm
  • Outer Diameter (Inner Limb): 6 mm
320006

  • Trachea prosthesis
BD 09 L 60
NOVATECH
04411
In Commercial Distribution

  • EBES044110 ()
  • EBES044111 ()
04411

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
BD 09 L 50
NOVATECH
04391
In Commercial Distribution

  • EBES043910 ()
  • EBES043911 ()
04391

  • Polymeric tracheal/bronchial stent, non-bioabsorbable
No Description
AMI Agency for Medical Innovations GmbH
RAR2081
In Commercial Distribution

  • EAMIRAR20810 ()
  • EAMIRAR20811 ()

  • Length: 97 Millimeter
  • Outer Diameter: 30 Millimeter
RAR2081

  • Noninvasive vascular ultrasound system
No Description
AMI Agency for Medical Innovations GmbH
RAR 2011
Not in Commercial Distribution

  • EAMIRAR20110 ()
  • EAMIRAR20111 ()
RAR 2011

  • Noninvasive vascular ultrasound system
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for powermorcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5551
In Commercial Distribution

  • MCS55511 ()
  • EAMIMCS55510 ()
MCS5551

  • Tissue extraction bag
More-Cell Bag is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5531
In Commercial Distribution

  • EAMIMCS55311 ()
  • EAMIMCS55310 ()
MCS5531

  • Tissue extraction bag
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for power morcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5511
In Commercial Distribution

  • EAMIMCS55110 ()
  • MCS55111 ()
MCS5511

  • Tissue extraction bag
FiXcision is an EO‐sterilized, single use, multi‐part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae.
AMI Agency for Medical Innovations GmbH
FIX2001
In Commercial Distribution

  • EAMIFIX20011 ()
  • EAMIFIX20010 ()
FIX2001

  • Anal fistula circular cutter
No Description
AMI Agency for Medical Innovations GmbH
EVI1011
Not in Commercial Distribution

  • EAMIEVI10111 ()
  • EAMIEVI10110 ()

  • Outer Diameter: 5 Millimeter
  • Length: 45 Millimeter
EVI1011

  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
AMI Agency for Medical Innovations GmbH
ESM1011
Not in Commercial Distribution

  • EAMIESM10111 ()
  • EAMIESM10110 ()

  • Outer Diameter: 3 Millimeter
  • Length: 21 Millimeter
ESM1011

  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
AMI Agency for Medical Innovations GmbH
ESI1210
Not in Commercial Distribution

  • EAMIESI12101 ()
  • EAMIESI12100 ()
ESI1210

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESI1151
Not in Commercial Distribution

  • EAMIESI11511 ()
  • EAMIESI11510 ()

  • Outer Diameter: 5 Millimeter
  • Length: 33 Millimeter
ESI1151

  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
AMI Agency for Medical Innovations GmbH
ESG1011
Not in Commercial Distribution

  • EAMIESG10111 ()
  • EAMIESG10110 ()

  • Outer Diameter: 5 Millimeter
  • Length: 50 Millimeter
ESG1011

  • Endoscopic electrosurgical electrode, monopolar, single-use
No Description
AMI Agency for Medical Innovations GmbH
EDI1051
Not in Commercial Distribution

  • EAMIEDI10511 ()
  • EAMIEDI10510 ()

  • Outer Diameter: 5 Millimeter
  • Length: 25 Millimeter
EDI1051

  • Endoscopic electrosurgical electrode, monopolar, single-use
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
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
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
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
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
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
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
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
No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0135162 ()
  • EFIAE0135161 ()


  • Nasal/paranasal balloon catheter
No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0135062 ()
  • EFIAE0135061 ()
E 01 3506

  • Nasal/paranasal balloon catheter
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
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
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
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
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
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
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
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
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
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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