AccessGUDID - DEVICE: SUPRA-FOLEY (H671SFS128520)

GUDID

Device Identifier (DI) Information

Brand Name: SUPRA-FOLEY
Version or Model: 12Fr Introducer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SF-S12-852
Company Name: UTAH MEDICAL PRODUCTS, INC.

Primary DI Number: H671SFS128520
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, 12 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":	Yes
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?
67060	Suprapubic catheter introducer, single-use	A rigid, tubular, manual device(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It typically includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve. 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: 12 French

Device Record Status

Public Device Record Key: ee7ccabd-098b-41e4-96f0-a63c1bee3a9f
Public Version Date: May 14, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016