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
00198506093593ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093777ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093807ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093814ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321060Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321070Surgical DirectSurgical Direct, Inc.LRC2026-07-29
00190776422080MillenniumAvalign Technologies, Inc.LRC2026-07-28
00198506092442ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092633ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092664ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092763ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092787ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092824ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093043ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093050ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093067ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093074ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093098ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093159ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093227ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506091896ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091902ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091971ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506093623ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04059453133809Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04250407786571FENTEXFENTEX medical GmbHLRC2024-08-01
04250407785765FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785772FENTEXFENTEX medical GmbHLRC2022-12-15