The Spanner Temporary Prostatic Stent

Basic Information

• Brand Name: The Spanner Temporary Prostatic Stent
• Primary DI: 00890477000050
• Version / Model: The Spanner Stent Size 9
• Company Name: SRS Medical Systems, Inc.
• Labeler DUNS: 796263598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b3fbb640-9a7d-428f-b27f-7a8e3f52c998

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: MR Unsafe
• 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
NZC	Stent, Urethral, Prostatic, Semi-Permanent	Unknown		3

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	00890477000050	GS1

Premarket Submissions

Submission Number	Supplement Number
P060010	011