FDA.reportPublic FDA data

Johlin

Primary DI
10827002256955
Brand
Johlin
Company
COOK IRELAND LTD
Model
G25695
Catalog number
JPWS-8.5-10
Device description
Johlin, Pancreatic Wedge Stent and Introducer
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
10827002256955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700225695510827002256955

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry location, away from temperature extremes.
Special Storage Condition, Specify00Store the device in a dry location
Special Storage Condition, Specify00Store the device in a dry location, Keep away from sunlight

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
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
10827002496665Geenen Sof-FlexG49666GPSO-SF-5-92015-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15