FDA.reportPublic FDA data

Fusion Titan

Primary DI
00827002492226
Brand
Fusion Titan
Company
COOK INCORPORATED
Model
G49222
Catalog number
FS-BDB-10X4
Device description
Fusion Titan Biliary Dilation Balloon 3.2mm
Published
2015-10-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002492226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002492226008270024922268270024922260827002492226

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/biliary dilation balloon catheterA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16932503514658Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515617Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515624Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515631Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515648Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515655Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515662Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515679Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515686Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515693Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515709Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515716Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515723Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515730Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515747Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515754Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515761Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515778Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515785Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515792Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503515808Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-20
16932503513873Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513880Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513897Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503513903Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514627Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514634Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503514641Biliary Plastic Stent SetMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503515310Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01
16932503515327Biliary Plastic StentMicro-Tech (Nanjing) Co., Ltd.FGE2026-03-01