FDA.reportPublic FDA data

Quantum TTC

Primary DI
00827002226555
Brand
Quantum TTC
Company
COOK INCORPORATED
Model
G22655
Catalog number
QBD-6X3
Device description
Quantum TTC Biliary Balloon Dilator
Published
2015-11-03
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

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
00827002226555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002226555008270022265558270022265550827002226555

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
079720472
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08714729793328MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793335MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793342MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793359MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793366MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793373MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793380MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793397MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793403MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793410MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793427MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793434MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793441MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793458MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793465MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793472MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793489MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793496MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793502MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793519MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793526MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729793533MUSTANG™BOSTON SCIENTIFIC CORPORATIONFGE2016-08-04
08714729029618vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030638Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030645Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729030652Amplatz Anchor™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729079552Flexima™BOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113829vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113836vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24
08714729113843vanSonnenberg™ SumpBOSTON SCIENTIFIC CORPORATIONFGE2015-09-24