Needle

GUDID 08800019101789

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 ID08800019101789
NIH Device Record Key55b37c05-9c8a-4897-9ecc-6e3364fe30dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedle
Version Model NumberBMN2423
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 Usetrue
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
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [Primary]
GS108800019101789 [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 Usetrue
Device Is Sterilefalse

[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


[08800019101789]

Moist Heat or Steam Sterilization


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 [Needle]

08800019101611BMN2425
08800019101604BMN2423
08800019101598BMN2420
08800019101574BSN2625
08800019101567BSN2425
08800019101550BSN2225
08800019101536BSN2423
08800019101529BSN2123
08800019101512BSN2820
08800019101505BSN2420
08800019101499BSN2220
08800019101482BSNSET
08800019101796BMN2425
08800019101789BMN2423
08800019101772BMN2420
08800019101765BSN2625
08800019101758BSN2425
08800019101741BSN2225
08800019101734BSN2324
08800019101727BSN2123
08800019101710BSN2028
08800019101703BSN2420
08800019101697BSN2220
08800019101680BSNSET

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