FDA.report

Zimmon

Primary DI
00827002220751
Brand
Zimmon
Company
COOK IRELAND LTD
Model
G22075
Catalog number
ZPSOF-5-6
Device description
Zimmon Pancreatic 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
00827002220751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002220751008270022207518270022207510827002220751

GMDN Terms

TermDefinition
Polymeric pancreatic stent, non-bioabsorbableA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). 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 in a dry location, away from temperature extremes
Special Storage Condition, Specify00Store the device in a dry location

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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