| Primary Device ID | H671SFS181011 |
| NIH Device Record Key | 6a231f22-fe69-47dd-be6b-a78f3c045373 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUPRA-FOLEY |
| Version Model Number | 18Fr Catheterization Kit |
| Catalog Number | SF-S18-101 |
| 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 |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Catheter Gauge | 18 French |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H671SFS181010 [Primary] |
| HIBCC | H671SFS181011 [Package] Contains: H671SFS181010 Package: Box [5 Units] In Commercial Distribution |
| KOB | Catheter, Suprapubic (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-18 |
| Device Publish Date | 2016-09-23 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUPRA-FOLEY 76719318 5106915 Live/Registered |
FEMCARE LIMITED 2016-05-16 |