| Primary Device ID | 20841019110076 |
| NIH Device Record Key | 57e457cd-4363-4984-a2f6-d936dd103e0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sense Medical |
| Version Model Number | 10700 |
| 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 |
| Length | 10 Feet |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841019110072 [Primary] |
| GS1 | 10841019110079 [Package] Contains: 00841019110072 Package: [10 Units] In Commercial Distribution |
| GS1 | 20841019110076 [Package] Contains: 00841019110072 Package: [50 Units] In Commercial Distribution |
| HAM | Apparatus, Electrosurgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841019110076]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-07 |
| 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 |