B&L-Beta(W)

GUDID 08800019101635

B& L Biotech, inc.

Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system
Primary Device ID08800019101635
NIH Device Record Key7e968bdf-8c97-4aa3-b88b-32d1e21211f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameB&L-Beta(W)
Version Model NumberWL-B1
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 Batchfalse
Serial Numbertrue
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
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]
GS108800019101635 [Primary]

FDA Product Code

EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic
EKRPlugger, Root Canal, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [B&L-Beta(W)]

08800019101024WL-B1
08800019101635WL-B1

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