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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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STRADIS HEALTHCARE - M75257032290

No Description
STRADIS MEDICAL, LLC
570-3229
Not in Commercial Distribution

  • M75257032290 ()


  • Collection syringe adaptor, single-use

Ceramage - E23519460

Ceramage F-Gum-Br
SHOFU DENTAL CORPORATION
1946
In Commercial Distribution

  • E23519460 ()
1946

  • Dental prosthesis veneer resin

Amaris Flow - E22119461

The ideal addition to Amaris. Simple modelling of the incisal edge. Easy wetting. Fine canullae allows to apply small amounts.
VOCO GmbH
1946
In Commercial Distribution

  • E22119461 ()
1946

  • Dental composite resin

Assure - D798APP0

Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive

Auto-Fill® syringe kit - M20676000

The AUTO-FILL Syringe Kit is indicated for introduction of dilute lidocaine solutions into the subcutaneous tissue for the purposes of local anesthesia.
Vascular Solutions, Inc.
7600
Not in Commercial Distribution

  • M20676000 ()
  • M20676001 ()


  • Syringe autofill kit

audifon - EADF03410600217207189

audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.3
In Commercial Distribution

  • EADF03410600217207189 ()
03410600217207189

  • Hearing aid wireless-fitting computer-aided set

audifon - EADF034106002172068681

audifon APP
audifon GmbH & Co. KG
audifon APP 1.4.2
In Commercial Distribution

  • EADF034106002172068681 ()
03410600217206868

  • Hearing aid wireless-fitting computer-aided set

iOptima APP - J00714000630631

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software

iChiropro APP - J00714000510511

iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400051
In Commercial Distribution

  • J00714000510511 ()
1400051

  • Surgical power tool system control unit, line-powered

Grin App - D962GGA00001

No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGA00001 ()


  • Radiological PACS software
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