SUPRA-FOLEY SF-S14-104
GUDID H671SFS141041
Suprapubic Catheter Introducer Kit, 14 French
UTAH MEDICAL PRODUCTS, INC.
Suprapubic catheter introducer| Primary Device ID | H671SFS141041 |
| NIH Device Record Key | 7b44b386-c514-4ad7-8fe1-69d09c9d8236 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUPRA-FOLEY |
| Version Model Number | 14Fr Catheterization Kit |
| Catalog Number | SF-S14-104 |
| Company DUNS | 094651270 |
| Company Name | UTAH MEDICAL PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com | |
| Phone | 800-533-4984 |
| customer@utahmed.com |
Device Dimensions
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H671SFS141040 [Primary] |
| HIBCC | H671SFS141041 [Package] Contains: H671SFS141040 Package: Box [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K884061
FDA Product Code
| KOB | Catheter, Suprapubic (And Accessories) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-18 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [SUPRA-FOLEY]
| H671SFS181011 | Suprapubic Catheter Introducer Kit, 18 French |
| H671SFS168511 | Suprapubic Catheter Introducer, 16 French |
| H671SFS161001 | Suprapubic Catheter Introducer Kit, 16 French |
| H671SFS141041 | Suprapubic Catheter Introducer Kit, 14 French |
| H671SFS128521 | Suprapubic Catheter Introducer, 12 French |
Trademark Results [SUPRA-FOLEY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPRA-FOLEY 76719318 5106915 Live/Registered |
FEMCARE LIMITED 2016-05-16 |
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