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510(k) Data Aggregation
K Number
K091992Device Name
EIDOSMED, MODEL EDG4.0
Manufacturer
Date Cleared
2009-12-09
(160 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
EIDOSMED, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Eidosmed EDG is a depth gauge measuring device intended for various medical purposes including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants.
Device Description
The Eidosmed Electronic Depth Gauge (“EDG”) is a depth gauge measuring device intended for various medical purposes, including but not limited to, measuring the depth of a passageway in a bone or other tissue to enable insertion of properly sized screws and implants. In addition to mechanically measuring and displaying depth using an analog scale, the EDG displays this information using a digital readout. The EDG, referred to as the EDG 4.0 version, is a completely disposable device. It is intended to be used on one patient, over the course of one surgical procedure.
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