| Primary Device ID | 20841019108684 |
| NIH Device Record Key | de589a48-0c14-4658-a176-986e491865c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kirwan (Distributor Nidek Co., Ltd.) |
| Version Model Number | 18241-M991 |
| Company DUNS | 046355210 |
| Company Name | KIRWAN SURGICAL PRODUCTS 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 | 12 Feet |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841019108680 [Primary] |
| GS1 | 10841019108687 [Package] Contains: 00841019108680 Package: [10 Units] In Commercial Distribution |
| GS1 | 20841019108684 [Package] Contains: 00841019108680 Package: [50 Units] In Commercial Distribution |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841019108684]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-26 |
| 00841019122136 - Kirwan | 2024-07-10 Reusable Bipolar Forceps with Tip Angled Down 45 Degrees at 3mm, Insulate to the Angle, and 6" Working Length (Special) |
| 00841019122129 - Kirwan | 2024-07-08 Reusable Bipolar Forceps with Irrigation (Special) |
| 00841019122143 - Kirwan | 2024-07-08 Reusable Bipolar Forceps with Tips Angled 10 Degrees Up (Special) |
| 00841019122068 - Kirwan | 2024-06-17 Reusable Bipolar Forceps with Axial Bayonet, Irrigation, and Tips Like Spetzler Tips (Tip Ends Meet First) (Special) |
| 00841019122075 - Kirwan | 2024-06-17 Reusable Bipolar Forceps with Axial Bayonet, Irrigation, and Tips Like Spetzler Tips (Tip Ends Meet First) (Special) |
| 00841019122082 - Kirwan | 2024-06-17 Reusable Bipolar Forceps with Axial Bayonet, Irrigation, and Tips Like Spetzler Tips (Tip Ends Meet First) (Special) |
| 00841019122099 - Kirwan | 2024-06-17 Reusable Bipolar Forceps with Axial Bayonet, Irrigation, and Tips Like Spetzler Tips (Tip Ends Meet First) (Special) |
| 00841019122020 - Kirwan | 2024-06-14 Reusable Bipolar Forceps with Axial Bayonet, 7" Total Length, 7mm Exposed Tip Length, "NM01" Marked on the Cup, and Tips like Sp |