Pro Endo Mirror

GUDID 08800019151562

B& L Biotech, inc.

Dental mirror, reusable
Primary Device ID08800019151562
NIH Device Record Keyc5f353a8-0f25-4389-aea3-8b2ee5bc5ed8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro Endo Mirror
Version Model NumberPEM
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
GS108800019151562 [Primary]

FDA Product Code

EAXMirror, Mouth

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


[08800019151562]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-08
Device Publish Date2025-04-30

Devices Manufactured by B& L Biotech, inc.

08800019151289 - PVS Tip2025-05-08
08800019151296 - PVS Tip2025-05-08
08800019151302 - PVS Tip2025-05-08
08800019151548 - Endodontic Explorer2025-05-08
08800019151555 - Dental Mirror Handle2025-05-08
08800019151562 - Pro Endo Mirror2025-05-08
08800019151562 - Pro Endo Mirror2025-05-08
08800019151586 - Dental Mirror2025-05-08
08800019151593 - DB Tip2025-05-08

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