BB8 Sinus Dilation Kit

GUDID 00860008118707

excelENT, Inc.

Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter Nasal/paranasal balloon catheter
Primary Device ID00860008118707
NIH Device Record Key15a3ad43-3944-4a9b-a0d6-96e414f8cfe0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBB8 Sinus Dilation Kit
Version Model Number033274
Company DUNS119131051
Company NameexcelENT, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008118707 [Primary]

FDA Product Code

LRCInstrument, Ent Manual Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-14
Device Publish Date2023-11-06

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