Starter Kit H4908NN
GUDID 00841436109369
Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare S4-10 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
Electromagnetic device tracking system fiducial marker Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system Electromagnetic surgical navigation device tracking system| Primary Device ID | 00841436109369 |
| NIH Device Record Key | ecf161d3-6a97-4d11-afe1-7342cd4f8e82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Starter Kit |
| Version Model Number | H4908NN |
| Catalog Number | H4908NN |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 |
Device Dimensions
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
| Width | 1.73 Inch |
| Length | 2.27 Inch |
Operating and Storage Conditions
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436109369 [Primary] |
| GS1 | 20841436116859 [Direct Marking] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092619
FDA Product Code
| IYO | System, imaging, pulsed echo, ultrasonic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-25 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [Starter Kit]
| 00841436109444 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436109437 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436109352 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436109345 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436109338 | Reusable non-sterile Volume Navigation Sensor bracket with (11.9 tapered to 3.8 x 61cm) CIV-Flex |
| 00841436109123 | Reusable non-sterile Volume Navigation Sensor bracket with (17.8 x 147cm) CIV-Flex™ covers (5 |
| 00841436108935 | Reusable non-sterile Volume Navigation Sensor bracket with (8.9 x 91.5cm) CIV-Flex™ covers (5) |
| 00841436108904 | Reusable non-sterile Volume Navigation Sensor bracket with (9 x 91.5cm) CIV-Flex™ covers (5) f |
| 00841436109369 | Reusable non-sterile Volume Navigation Sensor bracket with (14 x 91.5cm) CIV-Flex™ covers (5) |
Trademark Results [Starter Kit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STARTER KIT 90670217 not registered Live/Pending |
Shenzhen Freenove Creative Technology Co., Ltd. 2021-04-25 |
 STARTER KIT 75645402 2428837 Dead/Cancelled |
Diagonale, Jeffrey Dean 1999-02-22 |
 STARTER KIT 75332952 not registered Dead/Abandoned |
Corinthian Group, The 1997-07-30 |
 STARTER KIT 75227177 not registered Dead/Abandoned |
Cliffco of Tampa Bay, Inc. 1997-01-17 |
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