Endo R, M&R

GUDID 08800019140542

Endo M Ring Large Dark gray

B& L Biotech, inc.

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Primary Device ID08800019140542
NIH Device Record Key10b11530-126f-43e2-bda9-8843d20b6aef
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo R, M&R
Version Model NumberENMRLG
Company DUNS687338285
Company NameB& L Biotech, inc.
Device Count1
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800019140542 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-23
Device Publish Date2023-06-15

On-Brand Devices [Endo R, M&R]

08800019140542Endo M Ring Large Dark gray
08800019140535Endo M Ring Medium Dark gray
08800019140528Endo M Ring Small Dark gray

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