Endo M, M&R

GUDID 08800019140481

Magnet&Strap

B& L Biotech, inc.

Medical ruler, reusable
Primary Device ID08800019140481
NIH Device Record Key4ea43682-9881-4f17-af83-d43fd1b866d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndo M, M&R
Version Model NumberENMSSG
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
GS108800019140481 [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

Devices Manufactured by B& L Biotech, inc.

08800019100157 - Plugger2024-11-04
08800019100195 - Plugger2024-11-04
08800019101543 - Needle2024-11-04
08800019110651 - POMO Black2023-06-23
08800019110668 - POMO White2023-06-23
08800019110675 - POMO Pink2023-06-23
08800019110712 - COMO Black2023-06-23
08800019110729 - COMO White2023-06-23

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