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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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Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BE4, ZimVie - External Ø4.0
In Commercial Distribution

  • 05744003810062 ()
80610175

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEB, ZimVie - External Ø3.75
In Commercial Distribution

  • 05744003810055 ()
80610174

  • Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy.
Coremedtech ApS
BEP, ZimVie - External Ø3.25
In Commercial Distribution

  • 05744003810048 ()
80610173

  • Dental implant abutment analog, intraoral-scanning, single-use
External Penile Rigidity Device that contains kit bag, battery vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007196 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, constriction rings, cylinder, lubricant, cylinder inserts, loading cone.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007189 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, battery vacuum pump, constriction rings, standard cylinder, insert cylinders, cylinder inserts, loading cone, lubricant and 9 volt battery
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007172 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, constriction rings, cylinder, insert cylinders, cylinder inserts, loading cone, lubricant and standard cylinder
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007165 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, battery vacuum pump,constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007158 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, battery vacuum pump, constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007141 ()


  • Penile vacuum device
Manual Operated device that contains kit bag, manual vacuum pump, constriction rings, cylinder, lubricant, comfort inserts, loading cone.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007134 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, battery vacuum pump,constriction rings, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007127 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, battery vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007110 ()


  • Penile vacuum device
Manual Operated device that contains kit bag, manual vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007103 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, battery vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone, 9 volt battery.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007097 ()


  • Penile vacuum device
External Penile Rigidity Device that contains kit bag, manual vacuum pump, tension systems, cylinder, lubricant, comfort inserts, loading cone.
AUGUSTA MEDICAL SYSTEMS, L.L.C.
External Penile Rigidity Device
In Commercial Distribution

  • 00852598007080 ()


  • Penile vacuum device
External fixation kit composed of: - Elbow fixator, left (1 pc); - Guide wire (1 pc); - Locking screw (1 pc).
CITIEFFE SRL
Elbow external fixator, left
Not in Commercial Distribution

  • 08032909623747 ()

  • Left
F4-2260

  • External orthopaedic fixation system, single-use, sterile
External fixation kit composed of: - Elbow fixator (1 pc); - Guide wire (1 pc); - Locking screw (1 pc).
CITIEFFE SRL
Elbow external fixator, right
Not in Commercial Distribution

  • 08032909623730 ()

  • Right
F4-2250

  • External orthopaedic fixation system, single-use, sterile
No Description
IMPLANET
External tibial alignment guide
In Commercial Distribution

  • 03607505401256 ()
540125

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
CARBOFIX ORTHOPEDICS LTD
External Compression Plate 48.0
In Commercial Distribution

  • 07290110200886 ()
PFT910480

  • Orthopaedic implant aiming arm
Part of the Piccolo Composite Ankle Arthrodesis Nailing System Handle Assembly.
CARBOFIX ORTHOPEDICS LTD
External Compression Plate 40.0
In Commercial Distribution

  • 07290110200879 ()
PFT910340

  • Orthopaedic implant aiming arm
5CCSYR,GLSSYR
Avanos Medical, Inc.
92410
In Commercial Distribution

  • 10193493924100 ()
  • 00193493924103 ()
18908

  • External pledget
No Description
Avanos Medical, Inc.
92421
Not in Commercial Distribution

  • 30680651924217 ()
  • 10680651924213 ()
189A40

  • External pledget
No Description
Avanos Medical, Inc.
92410
In Commercial Distribution

  • 30680651924101 ()
  • 10680651924107 ()
18908

  • External pledget
No Description
Avanos Medical, Inc.
92411
In Commercial Distribution

  • 30680651924118 ()
  • 10680651924114 ()
18913

  • External pledget
No Description
Avanos Medical, Inc.
92409
In Commercial Distribution

  • 30680651924095 ()
  • 10680651924091 ()
18907

  • External pledget
eCoin Patient Kit
Valencia Technologies Corporation
1011-1901
In Commercial Distribution

  • 00860007896965 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
eCoin Device Kit
Valencia Technologies Corporation
1011-2447
In Commercial Distribution

  • 00860007896903 ()
1011-2447

  • Tibial nerve implantable incontinence-control electrical stimulation system
Revi™ System Physician Kit is intended to provide physicians necessary device system components to support therapy.
BLUEWIND MEDICAL LTD
KA-9000-0002_US_CM
In Commercial Distribution

  • 07290017912332 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
Revi System Patient Kit intended for patient use containing device components to support therapy.
BLUEWIND MEDICAL LTD
KA-9000-0001_US_CM
In Commercial Distribution

  • 07290017912226 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
The Revi Clinician Programmer is an application that is the Revi system's interface.
BLUEWIND MEDICAL LTD
DV-9500-0001_US_CM
In Commercial Distribution

  • 07290017912035 ()


  • Tibial nerve implantable incontinence-control electrical stimulation system
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