| Primary Device ID | H671DCE1152 |
| NIH Device Record Key | 1418884c-fd91-4681-8991-0a037a0fc9b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C-LETZ |
| Version Model Number | Contoured LETZ Electrode |
| Catalog Number | DCE-115 |
| 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 | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-533-4984 |
| customer@utahmed.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H671DCE1150 [Primary] |
| HIBCC | H671DCE1151 [Package] Contains: H671DCE1150 Package: Box [10 Units] In Commercial Distribution |
| HIBCC | H671DCE1152 [Package] Contains: H671DCE1151 Package: Overpack [10 Units] In Commercial Distribution |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-18 |
| Device Publish Date | 2016-09-23 |
| H671DCE1252 | Conization Electrode, 9mm Radius, 13mm Deep |
| H671DCE1202 | Conization Electrode, 12mm Radius, 10mm Deep |
| H671DCE1152 | Conization Electrode, 11mm Radius, 18mm Deep |
| H671DCE1102 | Conization Electrode, 15mm Radius, 23mm Deep |