| Primary Device ID | 00841436101233 |
| NIH Device Record Key | e7920004-b0af-4733-868b-2ca7afe26e9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Classic Stepper |
| Version Model Number | 609-001 |
| Catalog Number | 609-001 |
| Company DUNS | 134614411 |
| Company Name | CIVCO MEDICAL INSTRUMENTS CO., 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(319)248-6502 |
| regulatory@civco.com |
| Length | 15.97 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436101233 [Primary] |
| GS1 | 20841436117832 [Direct Marking] |
| IWJ | System, applicator, radionuclide, manual |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-24 |
| Device Publish Date | 2017-08-22 |
| 00841436108768 | For use with GE Healthcare ERB transducers |
| 00841436111454 | For use with Esaote TRT33 transducers |
| 00841436107266 | For use with Siemens Endo-PII transducers |
| 00841436105835 | For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers |
| 00841436105774 | For use with GE Healthcare ERB transducers |
| 00841436105262 | For use with BK Medical 8658(8558), 8848 and E14CL4b transducers |
| 00841436105101 | For use with Hitachi Aloka Medical UST-672-5/7.5 transducers |
| 00841436101233 | For use with Best® Sonalis™ TRT TriView transducers |
| 00841436121101 | For use with GE E7CBL transducers |