FDA.reportPublic FDA data

Zimmon

Primary DI
00827002216402
Brand
Zimmon
Company
COOK IRELAND LTD
Model
G21640
Catalog number
ZSO-10-12
Device description
Zimmon Biliary Stent
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00827002216402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002216402008270022164028270022164020827002216402

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric biliary stent, non-bioabsorbableA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the device in a dry location
Special Storage Condition, Specify00This device must be stored in a dry location, away from temperature extremes

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
988559035
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
00827002315181EchoTipG31518ECHO-1-222016-09-24
00827002315198EchoTipG31519ECHO-252016-09-24
00827002315204EchoTipG31520ECHO-192016-09-24
00827002347854EchoTip ProCoreG34785ECHO-HD-3-20-C2016-09-24
00827002535855EchoTip ProCoreG53585ECHO-HD-19-C2016-09-24
00827002557369EchoTip ProCoreG55736ECHO-HD-22-C2016-09-24
00827002557383EchoTip ProCoreG55738ECHO-HD-25-C2016-09-24
00827002491427Fusion MarathonG49142FS-MAR-10-52015-10-24
10827002256948JohlinG25694JPWS-8.5-82015-10-24
10827002256955JohlinG25695JPWS-8.5-102015-10-24
10827002257136JohlinG25713JPWS-10-82015-10-24
10827002257143JohlinG25714JPWS-10-102015-10-24
10827002257150JohlinG25715JPWS-10-122015-10-24
10827002257167JohlinG25716JPWS-10-142015-10-24
00827002214392ZimmonG21439ZEBD-11.5-52015-10-24
00827002214422ZimmonG21442ZEBD-11.5-72015-10-24
00827002214460ZimmonG21446ZEBD-11.5-92015-10-24
00827002222076ZimmonG22207ZEBD-11.5-122015-10-24
00827002224421ZimmonG22442ZEBD-11.5-152015-10-24
10827002496658Geenen Sof-FlexG49665GPSO-SF-5-72015-11-03

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