| Primary Device ID | 00841436123013 |
| NIH Device Record Key | 8558edb2-0488-4613-b715-f205f84c7ed1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HLD Starter Kit |
| Version Model Number | 610-2474 |
| Catalog Number | 610-2474 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436123013 [Primary] |
| MED | Sterilant, medical devices |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-11 |
| Device Publish Date | 2023-05-03 |
| 20841436122584 - Needle Guide Bracket | 2024-02-16 Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta L18X transducers |
| 20841436122614 - Needle Guide Bracket | 2024-02-16 Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta MC10-3 transducers |
| 20841436123161 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Esaote C 1-8E and CX 1-8A transducers |
| 20841436123314 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung CMV1-10 transducers |
| 20841436124335 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Canon Medical Systems 12L4 transducers |
| 20841436124939 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung LA2-16S transducers |
| 20841436124960 - Biopsy Bracket | 2024-02-16 Reusable non-sterile Verza™ bracket for use with Samsung L3-22 transducers |
| 00841436120913 - Transducer Cover | 2024-02-16 Non-sterile (14 x 147cm) telescopically- folded CIV-Flex cover with Envision |