| Primary Device ID | 00841436106047 |
| NIH Device Record Key | d478d539-2685-4f46-98ba-073a381411ff |
| Commercial Distribution Discontinuation | 2020-05-19 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Tracking Bracket |
| Version Model Number | 653-001 |
| Catalog Number | 653-001 |
| 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 | 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 | 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 |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 Inch |
| Width | 1.57 Inch |
| Length | 1.89 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436106047 [Package] Contains: 10841436106044 Package: [12 Units] Discontinued: 2020-05-19 Not in Commercial Distribution |
| GS1 | 10841436106044 [Primary] |
| IYO | System, imaging, pulsed echo, ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
[00841436106047]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-09-03 |
| Device Publish Date | 2017-08-22 |
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