| Primary Device ID | 00841436118705 |
| NIH Device Record Key | be0fd04c-06bd-4d56-bab8-98245c57ac3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integrated Needle Guide |
| Version Model Number | 680-172, 680-172-5 |
| Catalog Number | 680-172, 680-172-5 |
| 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 | 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 | true |
| 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 |
| 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 |
| 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 |
| 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 | 00841436118705 [Package] Contains: 10841436118702 Package: [12 Units] In Commercial Distribution |
| GS1 | 00841436118736 [Package] Contains: 10841436118702 Package: [5 Units] In Commercial Distribution |
| GS1 | 10841436118702 [Primary] |
| IYO | System, imaging, pulsed echo, ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
[00841436118705]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-29 |
| Device Publish Date | 2021-11-20 |
| 00841436109093 | Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with GE |
| 00841436118705 | Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with Ca |