FDA.reportPublic FDA data

Cook

Primary DI
00827002215832
Brand
Cook
Company
COOK IRELAND LTD
Model
G21583
Catalog number
ENBD-5
Device description
Nasal Biliary Drainage Set
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
00827002215832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002215832008270022158328270022158320827002215832

GMDN Terms#

Term, Definition table
TermDefinition
Nasal biliary/pancreatic drainage catheterA sterile, flexible tube intended to be introduced endoscopically for the temporary drainage of the biliary and/or pancreatic duct. It is intended to navigate to the biliary and/or pancreatic tract via the sphincter of Oddi, and terminate proximally via the nasal passage; devices associated with catheter introduction/connection (excluding the endoscope) may be included (e.g., nasal transfer tube, drainage connecting tube, guidewire), however it does not include any fluid collection bags/containers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store 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
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06959664929100NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15