| Primary Device ID | 00841436105378 |
| NIH Device Record Key | 5c2f4a7d-2259-49e8-a1bc-d03e17d2e7da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multi-Purpose Workstation™ Stepper |
| Version Model Number | 620-117 |
| Catalog Number | 620-117 |
| 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 | false |
| 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 | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com | |
| Phone | +1(319)248-6502 |
| regulatory@civco.com |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Length | 9.58 Inch |
| Height | 5.78 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436105378 [Primary] |
| GS1 | 20841436117993 [Direct Marking] |
| ITX | Transducer, ultrasonic, diagnostic |
| 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 |
| 20841436118587 | For use with Terason 8BP4 transducers |
| 00841436107280 | For use with Siemens Endo-PII transducers |
| 00841436105842 | For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers |
| 00841436105781 | For use with GE Healthcare ERB transducers |
| 00841436105378 | For use with BK Medical 8848 and E14CL4b transducers |
| 00841436105354 | For use with BK Medical 8808e, 8818 and E14C4t transducers |
| 00841436105279 | For use with BK Medical 8658 (8558) and 8808 transducers |
| 00841436105149 | For use with Hitachi Aloka Medical UST-672-5/7.5 transducers |
| 00841436121149 | For use with GE E7C8L trasducers |
| 00841436121187 | For use with BK Medical 8848, E14CL4b and Tarson 8BP4 transducers |
| 00841436115131 | For use with Mindray 6LB7 transducers |