| Primary Device ID | 20841019110083 |
| NIH Device Record Key | 80c0068c-0b71-47ce-8a54-7f0fd677e5d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sense Medical |
| Version Model Number | 14500 |
| Company DUNS | 159526008 |
| Company Name | SENSE MEDICAL LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 781-834-9500 |
| kprario@ksp.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841019110089 [Primary] |
| GS1 | 10841019110086 [Package] Contains: 00841019110089 Package: [10 Units] In Commercial Distribution |
| GS1 | 20841019110083 [Package] Contains: 00841019110089 Package: [50 Units] In Commercial Distribution |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841019110083]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-16 |
| 20841019110090 | Disposable 23 Gauge Bipolar Pencil Tapered Tip |
| 20841019110083 | Bipolar Pencil 18 Gauge Straight |
| 20841019110076 | Single Use Monopolar Suction Coagulator 10 French with 10ft. (3m) Monopolar Cord |
| 00841019110065 | Reusable Bipolar Coagulation Cord 12ft. (3.6m) Silicone |