FDA.reportPublic FDA data

Cook 810

Primary DI
00827002150799
Brand
Cook 810
Company
COOK INCORPORATED
Model
G15079
Catalog number
030000-S1
Device description
Cook 810 Set
Published
2019-11-26
Public version status
New
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
00827002150799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002150799008270021507998270021507990827002150799

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

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
03600040255728Porges ColoplastColoplast A/SEZN2019-06-30
03600040255773Porges ColoplastColoplast A/SEZN2019-06-30