FDA.reportPublic FDA data

BB 8 Sinus Dilation Kit

Primary DI
00860013723903
Brand
BB 8 Sinus Dilation Kit
Company
excelENT, Inc.
Model
EXM-01-020-125
Published
2025-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013723903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013723903008600137239038600137239030860013723903

GMDN Terms#

Term, Definition table
TermDefinition
Nasal/paranasal balloon catheterA sterile flexible tube with an inflatable balloon at its distal tip designed to gently restructure nasal passages and dilate obstructed sinus ostia during a surgical procedure (sinuplasty), typically to treat sinusitis, and/or to gently restructure nasal passages to temporarily relieve nasal obstruction/congestion. The device typically consists of a single-lumen tube with a connector at the proximal end for attachment to an inflation device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119131051
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008118707BB8 Sinus Dilation Kit0332742023-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250407741976FENTEXFENTEX medical GmbHLRC2023-06-14
04250407729448FENTEXFENTEX medical GmbHLRC2022-12-12
04250407730406FENTEXFENTEX medical GmbHLRC2022-12-12
04250407731328FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732288FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732295FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732332FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732912FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732929FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732936FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732943FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732950FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733063FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733865FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733872FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734282FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734466FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734473FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734480FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734497FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734794FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734947FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734954FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734961FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734978FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734985FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734992FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735005FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735203FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735210FENTEXFENTEX medical GmbHLRC2022-12-12