FDA.reportPublic FDA data

Desilets-Hoffman

Primary DI
00827002180895
Brand
Desilets-Hoffman
Company
COOK INCORPORATED
Model
G18089
Catalog number
DHIS-080030-RB-DIL88
Device description
Desilets-Hoffman Introducer Set With Radiopaque Band
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZNDILATOR, CATHETER, URETERAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZNDilator, Catheter, UreteralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002180895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002180895008270021808958270021808950827002180895

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042823948
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
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03600040975312ColoplastColoplast A/SEZN2024-07-09
03600040975343ColoplastColoplast A/SEZN2024-07-09
03600040975336ColoplastColoplast A/SEZN2024-07-09
03600040975367ColoplastColoplast A/SEZN2024-07-09
03600040911051ColoplastColoplast A/SEZN2024-05-21
03600040911082ColoplastColoplast A/SEZN2024-05-21
03600040953792ColoplastColoplast A/SEZN2024-05-21
03600040911068ColoplastColoplast A/SEZN2024-05-21
03600040911105ColoplastColoplast A/SEZN2024-05-21
03600040953808ColoplastColoplast A/SEZN2024-05-21
03600040953761ColoplastColoplast A/SEZN2024-05-10
03600040953785ColoplastColoplast A/SEZN2024-05-10
03600040953679ColoplastColoplast A/SEZN2024-04-12
03600040953709ColoplastColoplast A/SEZN2024-04-12
03600040953730ColoplastColoplast A/SEZN2024-04-12
03600040953693ColoplastColoplast A/SEZN2024-04-12
03600040953716ColoplastColoplast A/SEZN2024-04-12
03600040953747ColoplastColoplast A/SEZN2024-04-12
00812261012605ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
00812261012612ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
10812261012602ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
10812261012619ARMADAALLWIN MEDICAL DEVICES, INC.EZN2023-07-31
03600040325117Porges ColoplastColoplast A/SEZN2020-06-19
03600040325148Porges ColoplastColoplast A/SEZN2020-06-19
03600040325179Porges ColoplastColoplast A/SEZN2020-06-19
05708932727501Porges ColoplastColoplast A/SEZN2020-06-19
05708932727532Porges ColoplastColoplast A/SEZN2020-06-19
05708932727563Porges ColoplastColoplast A/SEZN2020-06-19
00827002150799Cook 810COOK INCORPORATEDEZN2019-11-26
03600040255728Porges ColoplastColoplast A/SEZN2019-06-30