AccessGUDID - DEVICE: SUPRA-FOLEY (H671SFS161000)

GUDID

Device Identifier (DI) Information

Brand Name: SUPRA-FOLEY
Version or Model: 16Fr Catheterization Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SF-S16-100
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671SFS161000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094651270 *Terms of Use

Device Description: Suprapubic Catheter Introducer Kit, 16 French

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?
67191	Suprapubic catheterization kit	A collection of devices intended for the percutaneous introduction of an included catheter into the bladder through a suprapubic (above the pubic arch) incision, for the drainage of urine. In addition to the suprapubic catheter, it includes an introducer (typically a cannula/sheath with trocar), and one or more non-dedicated procedural supportive devices (e.g., scalpel, dressing, gauze, drape, disinfectant); it does not include a pharmaceutical. 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 [?]
K884061	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: 16 French

Device Record Status

Public Device Record Key: 69abe716-8809-4aa3-b71d-b93fc52e6727
Public Version Date: May 23, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016