Endo R

GUDID 08800019140108

B& L Biotech, inc.

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Primary Device ID08800019140108
NIH Device Record Key3bfbcd6d-6688-4327-aebe-281069e6eddf
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo R
Version Model NumberENMRMG-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
GS108800019140108 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


[08800019140108]

Moist Heat or Steam Sterilization


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]

08800019140122ENMRLG-R
08800019140108ENMRMG-R
08800019140085ENMRSG-R

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