FDA.report

Zimmon

Primary DI
00827002219984
Brand
Zimmon
Company
COOK IRELAND LTD
Model
G21998
Catalog number
ZSO-6-10
Device description
Zimmon Biliary Stent
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

Related Records

Contact Domains

Product Codes

CodeName
FGECATHETER, BILIARY, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00827002219984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002219984008270022199848270022199840827002219984

GMDN Terms

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

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

Contacts

PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags

DUNS number
988559035
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

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10827002256702SolusG25670ZSS-10-3-RB2015-10-24
10827002256719SolusG25671ZSS-10-4-RB2015-10-24
10827002256726SolusG25672ZSS-10-5-RB2015-10-24
10827002256733SolusG25673ZSS-10-7-RB2015-10-24
10827002256740SolusG25674ZSS-10-9-RB2015-10-24
10827002256757SolusG25675ZSS-10-12-RB2015-10-24
10827002256764SolusG25676ZSS-10-15-RB2015-10-24
10827002256856SolusG25685ZSS-10-10-RB2015-10-24
10827002268293SolusG26829ZSS-10-1-RB2015-10-24
10827002496559Cotton-Leung Sof-FlexG49655CLSO-SF-10-92015-11-03
10827002496566Cotton-Leung Sof-FlexG49656CLSO-SF-10-122015-11-03
10827002496580Cotton-Leung Sof-FlexG49658CLSO-SF-7-52015-11-03
10827002496597Cotton-Leung Sof-FlexG49659CLSO-SF-7-72015-11-03
10827002496610Cotton-Leung Sof-FlexG49661CLSO-SF-7-122015-11-03
10827002496627Cotton-Leung Sof-FlexG49662CLSO-SF-7-152015-11-03
10827002496658Geenen Sof-FlexG49665GPSO-SF-5-72015-11-03
10827002496665Geenen Sof-FlexG49666GPSO-SF-5-92015-11-03
10827002496672Geenen Sof-FlexG49667GPSO-SF-5-122015-11-03
10827002496719Geenen Sof-FlexG49671GPSOS-SF-5-92015-11-03
10827002496726Geenen Sof-FlexG49672GPSOS-SF-5-122015-11-03

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