COMO Tip

GUDID 08800019111276

B& L Biotech, inc.

Dental material application tool, reusable
Primary Device ID08800019111276
NIH Device Record Key115667f0-9fa9-4953-b704-d8dfc378ba99
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMO Tip
Version Model NumberCD2
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
GS108800019111276 [Primary]

FDA Product Code

KXRApplicator, Resin

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

Moist Heat or Steam Sterilization


[08800019111276]

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

On-Brand Devices [COMO Tip]

08800019111351VC4
08800019111344VC3
08800019111337VC2
08800019111320VC1
08800019111313RD3
08800019111306RD2
08800019111290RD1
08800019111283CD3
08800019111276CD2
08800019111269CD1
08800019110774CT4
08800019110767CT3
08800019110750CT2
08800019110743CT1

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.