Tarkington

Basic Information

• Brand Name: Tarkington
• Primary DI: 00827002156142
• Version / Model: G15614
• Catalog Number: 032408
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ada98d6a-9c09-44e7-9a23-6982645e487d

Device Description

Tarkington Urethral Stent Set

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: No
• 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
KOD	CATHETER, UROLOGICAL	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47035	Polymeric urethral stent, short-term	A sterile non-bioabsorbable tubular device intended for short-term (<= 30 days) introduction into the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder, typically used during the postsurgical healing period [e.g., after thermal treatment of benign prostatic hyperplasia (BPH) or hypospadias/epispadias repair], or to relieve urethral obstruction from BPH and/or detrusor external sphincter dyssynergia (DESD). It is made entirely of a synthetic polymer(s) and may have various designs (e.g., continuous tube, meshed). It may be expandable in situ and disposable devices intended to assist implantation may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002156142	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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