T-SPeC

Basic Information

• Brand Name: T-SPeC
• Primary DI: 00856995003010
• Version / Model: T14
• Catalog Number: 114
• Company Name: SWAN VALLEY MEDICAL, INCORPORATED
• Labeler DUNS: 795608012
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-10
• Public Version: 3
• Public Version Date: 2020-04-01
• Public Version Status: Update
• Public Device Record Key: 591d7a18-0c9c-4b89-8f53-8acc75579f89

Device Description

Transurethral Suprapubic endo-Cystostomy

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	876.5090	2
FEX	Instrument, Catheter, Punch	Gastroenterology, Urology	876.5090	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34924	Suprapubic drainage catheter	A sterile, flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a male or female patient primarily for the drainage of urine, however it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube which may have one of a variety of hole/tip configurations at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856995003010	GS1
Previous	08569950031141	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120127	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	18	French