AccessGUDID - DEVICE: T-SPeC (00856995003010)

GUDID

Device Identifier (DI) Information

Brand Name: T-SPeC
Version or Model: T14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 114
Company Name: SWAN VALLEY MEDICAL, INCORPORATED

Primary DI Number: 00856995003010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 795608012 *Terms of Use
Previous DI: 08569950031141

Device Description: Transurethral Suprapubic endo-Cystostomy

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
34924	Suprapubic drainage catheter	A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips 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; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOB	Catheter, Suprapubic (And Accessories)
FEX	Instrument, Catheter, Punch

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120127	000

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
Catheter Gauge: 18 French

Device Record Status

Public Device Record Key: 591d7a18-0c9c-4b89-8f53-8acc75579f89
Public Version Date: May 16, 2024
Public Version Number: 4
DI Record Publish Date: March 10, 2020