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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 non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive intended to be used as an alternative to injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device.
AXELGAARD MANUFACTURING CO., LTD.
Ionto480 DDS275
In Commercial Distribution

  • 00856817005888 ()

  • 1.5 cc fill volume
DDS275

  • Drug-delivery iontophoresis patch
Manual - Ratchet - Fix Key for Implant - Extra Extra Long L.25 mm. - CC
FAICO MEDICAL LLC
AST00250APCRC
Not in Commercial Distribution

  • 00840192716408 ()


  • Dental implant system
5.3 cc Vaginal Cream Applicator 3-Pack. Three applicators are packaged in a canister.
Pce, Inc.
Q033-G00-02
In Commercial Distribution

  • 00860009492912 ()


  • Vaginal applicator, single-use
Pig, Double-Ended, PET, .6" lead, accommodates 5 cc syringes with or without needle
BIODEX MEDICAL SYSTEMS, INC.
001-793
In Commercial Distribution

  • 00718175001806 ()
001-793

  • Radiation shielding container, transport/transfer
Pig, Unit Dose, Zevalin In-111, accommodates 10 cc syringe with or without needle
BIODEX MEDICAL SYSTEMS, INC.
001-789
In Commercial Distribution

  • 00718175001790 ()
001-789

  • Radiation shielding container, transport/transfer
Pig, Unit Dose, Zevalin Y-90, accommodates 10 cc syringes with or without needle
BIODEX MEDICAL SYSTEMS, INC.
001-788
In Commercial Distribution

  • 00718175001783 ()
001-788

  • Radiation shielding container, transport/transfer
Lab Screw Implant Level CC RP/WP and Ext Hex RP 5/pkg
Nobel Biocare AB
37895
In Commercial Distribution

  • 07332747150292 ()
  • 07332747212303 ()
37895

  • Dental implant suprastructure, temporary, preformed, reusable
RIVAL TI CC PLATE LARGE (present record replaces device with Primary DI: 18053800893517
ORTHOFIX SRL
2
In Commercial Distribution

  • 18053340341035 ()
002-G-01030

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
RIVAL TI CC PLATE MEDIUM (present record replaces device with Primary DI: 18053800893500
ORTHOFIX SRL
2
In Commercial Distribution

  • 18053340341028 ()
002-G-01025

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
RIVAL TI CC PLATE SMALL (present record replaces device with Primary DI: 18053800893494
ORTHOFIX SRL
2
In Commercial Distribution

  • 18053340341011 ()
002-G-01020

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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