FDA.reportPublic FDA data

STANDARD BALLOON CATHETER SILICONE

Primary DI
00821925022355
Brand
STANDARD BALLOON CATHETER SILICONE
Company
Gyrus Acmi, Inc.
Model
890923
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMXBALLOON, EPISTAXIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925022355PackageGS16In Commercial Distribution
00821925040342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925022355008219250223558219250223550821925022355
00821925040342008219250403428219250403420821925040342

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
007198742
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925043916SOLTIVETFL-FBX150BS2024-08-01
00821925043930SOLTIVETFL-FBX200S2024-08-01
00821925043978SOLTIVETFL-FBX200BS2024-08-01
00821925043992SOLTIVETFL-FBX365S2024-08-01
00821925044074SOLTIVETFL-FBX940S2024-08-01
00821925002074USA Elite SystemEOS-CFR-252024-07-25
00821925002098USA Elite SystemEOS-HCF252024-07-25
00821925002111USA Elite SystemERIS-CF252024-07-25
00821925002128USA Elite SystemERIS-CF272024-07-25
00821925002159USA Elite SystemERLB-7.52024-07-25
00821925002166USA Elite SystemEROS-CF252024-07-25
00821925002173USA Elite SystemEROS-CF272024-07-25
00821925002586Gyrus ACMI1942024-07-25
00821925007482Gyrus ACMIRFG-31152024-07-25
00821925008076Bovie5686012024-07-25
00821925008083Bovie5686042024-07-25
00821925008458Bovie5686052024-07-25
00821925008908Gyrus ACMIG2152-322024-07-25
00821925009523IRRI-FLO I 59200002024-07-25
00821925011427DIEGO703390502024-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10855364004112Rhino-Pak 45mmMAR-MED INC.EMX2025-02-06
00855364004122Rhino-Pak 55mmMAR-MED INC.EMX2025-02-06
10855364004136Rhino-Pak 75mmMAR-MED INC.EMX2025-02-06
00821925030831Gyrus ACMIGyrus ACMI, LLCEMX2024-11-26
00821925022379Gyrus ACMIGyrus Acmi, Inc.EMX2024-07-25
30886158012222Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012239Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012246Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012253Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012260Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012284Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012291Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012314Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012321Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012338Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012345Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012352Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012369Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012376Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012383Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012390Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012406Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012437Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012444Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158012451Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013243Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013267Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013274Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013281Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27
30886158013298Ultracell®Beaver-Visitec International, Inc.EMX2024-06-27