| Primary Device ID | 00827002012585 |
| NIH Device Record Key | a6a0c553-7d30-43fe-95e0-f554c3ff9f1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kopans |
| Version Model Number | G01258 |
| Catalog Number | DKBL-21-15.0 |
| Company DUNS | 042823948 |
| Company Name | COOK INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dark, dry, cool place. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00827002012585 [Primary] |
| MIJ | NEEDLE, TUMOR LOCALIZATION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-12 |
| Device Publish Date | 2020-10-02 |
| 00827002301825 | Kopans Breast Lesion Localization Needle |
| 00827002269774 | Kopans Breast Lesion Localization Needle Inconel |
| 00827002269767 | Kopans Breast Lesion Localization Needle Inconel |
| 00827002121607 | Kopans Breast Lesion Localization Needle Inconel |
| 00827002099852 | Kopans Breast Lesion Localization Needle With Echotip |
| 00827002099845 | Kopans Breast Lesion Localization Needle With Echotip |
| 00827002090422 | Kopans Breast Lesion Localization Needle With Echotip |
| 00827002073708 | Kopans Breast Lesion Localization Needle With Echotip |
| 00827002058620 | Kopans Breast Lesion Localization Needle With Echotip |
| 00827002053465 | Kopans Breast Lesion Localization Needle |
| 00827002043435 | Kopans Breast Lesion Localization Needle With Echotip |
| 00827002042964 | Kopans Breast Lesion Localization Needle With Echotip |
| 00827002042933 | Kopans Breast Lesion Localization Needle With Echotip |
| 00827002042711 | Disposable Kopans Spring Hook Support Cannula |
| 00827002040601 | Disposable Kopans Spring Hook Support Cannula |
| 00827002040533 | Disposable Kopans Spring Hook Support Cannula |
| 00827002037953 | Kopans Breast Lesion Localization Needle |
| 00827002035072 | Kopans Breast Lesion Localization Needle |
| 00827002029385 | Kopans Breast Lesion Localization Needle |
| 00827002029002 | Kopans Breast Lesion Localization Needle |
| 00827002028500 | Kopans Breast Lesion Localization Needle |
| 00827002026018 | Kopans Breast Lesion Localization Needle |
| 00827002025875 | Kopans Breast Lesion Localization Needle |
| 00827002025868 | Kopans Breast Lesion Localization Needle |
| 00827002025547 | Kopans Breast Lesion Localization Needle |
| 00827002012585 | Kopans Breast Lesion Localization Needle |
| 00827002011939 | Kopans Breast Lesion Localization Needle |