REAMER EPO1662

GUDID 00841494104375

REAMER SIZE 2

Ellman International

Pin/post dental drill bit
Primary Device ID00841494104375
NIH Device Record Key587c710b-863a-4b89-975f-2fc310adb735
Commercial Distribution StatusIn Commercial Distribution
Brand NameREAMER
Version Model NumberEPO1662
Catalog NumberEPO1662
Company DUNS079095245
Company NameEllman International
Device Count6
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841494104375 [Primary]
GS100841494106355 [Unit of Use]

FDA Product Code

ELRPOST, ROOT CANAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2016-09-21

On-Brand Devices [REAMER]

00841494104399REAMER, SIZE 1
00841494104382REAMER SIZE 3
00841494104375REAMER SIZE 2

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