Endo M, R, M&R

GUDID 08800019140603

Endo M Main Body DLC Right (2EA)

B& L Biotech, inc.

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Primary Device ID08800019140603
NIH Device Record Key1dd0ba4e-b04a-45d7-9376-644caf0c8da2
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo M, R, M&R
Version Model NumberENMMB2-R
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
GS108800019140603 [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 M, R, M&R]

08800019140610Endo M Main Body DLC Left (2EA)
08800019140603Endo M Main Body DLC Right (2EA)
08800019140597Endo M Main Body DLC Left (1EA)
08800019140580Endo M Main Body DLC Right (1EA)

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