Snare X5

Basic Information

• Brand Name: Snare X5
• Primary DI: 17290015518083
• Version / Model: MT-FA09
• Company Name: MEDI-TATE LTD
• Labeler DUNS: 532003626
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-20
• Public Version: 2
• Public Version Date: 2022-05-09
• Public Version Status: Update
• Public Device Record Key: 66846eb7-3168-412b-b967-fb1046e8d23d
• Distribution End Date: 2021-07-20

Device Description

Pack of 5 individually packed Snare

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
QKA	Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	876.5510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63402	Bare-metal urethral stent, short-term	A sterile non-bioabsorbable tubular device intended to be placed short-term (<= 30 days) in the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder; it is typically used to relieve lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is made entirely of metal [e.g., nickel-titanium alloy (Nitinol)] and is typically self-expanded in situ; disposable devices intended to assist implantation or removal (e.g., attached thread) may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290015518083	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN190020	000