AccessGUDID - DEVICE: S-Cath™ (05055140701336)

GUDID

Device Identifier (DI) Information

Brand Name: S-Cath™
Version or Model: 5760
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDIPLUS LTD

Primary DI Number: 05055140701336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 228480810 *Terms of Use

Device Description: S-Cath™ System - Silicone suprapubic Foley catheter, with introducer set, 12Fr. 10cc, 42cm

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 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOB	CATHETER, SUPRAPUBIC (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132890	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
Length: 42.0 Centimeter
Catheter Gauge: 12.0 French

Device Record Status

Public Device Record Key: 4ea13179-74e1-407b-a1b1-f9106ff15efe
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 17, 2015