Leetrac Wide handle

GUDID 08800019110903

B& L Biotech, inc.

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Primary Device ID08800019110903
NIH Device Record Keyd52048e6-ae75-4ee1-adf6-7ca7d071107e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeetrac Wide handle
Version Model NumberLRTNH
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
GS108800019110903 [Primary]

FDA Product Code

EMOKnife, Periodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

Moist Heat or Steam Sterilization


[08800019110903]

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

Devices Manufactured by B& L Biotech, inc.

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
08800019110736 - COMO Pink2023-06-23
08800019110743 - COMO Tip2023-06-23
08800019110750 - COMO Tip2023-06-23

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