AccessGUDID - DEVICE: The Spanner Temporary Prostatic Stent (00890477000036)

GUDID

Device Identifier (DI) Information

Brand Name: The Spanner Temporary Prostatic Stent
Version or Model: The Spanner Stent Size 7
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SRS Medical Systems, Inc.

Primary DI Number: 00890477000036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796263598 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZC	Stent, Urethral, Prostatic, Semi-Permanent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P060010	011

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d14d2aed-f8a5-4817-bde1-7205333b2c14
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2014