BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Cook

DI: 00827002154254 · Model: G15425 · COOK INCORPORATED

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Cook
Primary DI: 00827002154254
Version / Model: G15425
Catalog Number: 020014-S3
Company Name: COOK INCORPORATED
Labeler DUNS: 042823948
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-24
Public Version: 3
Public Version Date: 2019-02-07
Public Version Status: Update
Public Device Record Key: a8588bdc-716f-441d-a6e8-c61409c782bf
Distribution End Date: 2018-01-25

Device Description

Open-End Ureteral Catheter

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBL	CATHETER, URETERAL, GENERAL & PLASTIC SURGERY	Gastroenterology, Urology	876.5130	N

GMDN Terms

Code	Name	Definition	Implantable	Status
34926	Ureteral catheter	A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002154254	GS1

Customer Contacts

Phone: +1(812)330-5494
Email: [email protected]

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Store in dark, dry, cool place.