| Primary Device ID | 00841436107105 |
| NIH Device Record Key | 3fecdc5c-c327-40d9-8ffc-ed457ebb9829 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Needle Guide Bracket |
| Version Model Number | 674-047 |
| Catalog Number | 674-047 |
| 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 | |
| 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 | |
| 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 | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Length | 2.4 Inch |
| Height | 1.2 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| 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 |
| 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 | 00841436107105 [Primary] |
| GS1 | 20841436116415 [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 | 6 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2017-08-22 |
| 00841436110914 | Reusable non-sterile Infiniti Plus ™ bracket for use with FUJIFILM SonoSite, Inc. C11 transduc |
| 00841436109529 | Reusable non-sterile single-angle bracket for use with SonoSIte L25 series transducers |
| M001457100 | Reusable non-sterile single-angle bracket for use with SonoSite |
| 00841436107211 | Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM SonoSite |
| 00841436107204 | Reusable non-sterile bracket for use with FUJIFILM SonoSite |
| 00841436107174 | Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite L25 transducers |
| 00841436107167 | Reusable non-sterile bracket for use with FUJIFILM SonoSite L25 transducers |
| 00841436107150 | Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite |
| 00841436107129 | Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite |
| 00841436107112 | Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite |
| 00841436107105 | Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite |
| 00841436107099 | Reusable non-sterile bracket for use with FUJIFILM SonoSite |
| 00841436107082 | Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite |
| 00841436107075 | Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM SonoSite |
| 00841436107068 | Reusable non-sterile Infiniti Plus™ bracket for use with SonoSite |
| 20841436115333 | reusable non-sterile bracket for use with SonoSite L25 series transducers |
| 00841436118637 | Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM Sonosite L19-5 transducers |
| 00841436118613 | Reusable non-sterile AccuSITE™ bracket for use with FUJIFILM Sonosite L19-5 transducers |
| 00841436121644 | Reusable non-sterile Infiniti Plus™ bracket for use with FUJIFILM SonoSITE, Inc. C10-3 transd |
| 20841436122775 | Reusable non-sterile Infiniti Plus™ bracket for use with Terumo PS-DEZ335 transducers |
| 20841436122744 | Reusable non-sterileAccuSITE™ bracket for use with Terumo PS-DEZ335 transducers |
| 20841436122614 | Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta MC10-3 transducers |
| 20841436122584 | Reusable non-sterile Infiniti Plus™ bracket for use with Konica Minolta L18X transducers |
| 20841436123284 | Reusable non-sterile Infiniti Plus™ bracket for use with Siemens HLX transducers |