eTRAX™ Needle System Starter Kit 5451117
GUDID 00841436101073
Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8 x 147cm) CIV-Flex™ covers (5), Ultra-Pro e™ needle guides (5), (14 x 91.5cm) CIV-Flex™ covers (5)
CIVCO MEDICAL INSTRUMENTS CO., INC.
Electromagnetic surgical navigation device tracking system| Primary Device ID | 00841436101073 |
| NIH Device Record Key | 75da8954-b00c-470f-8db9-2f7a5f08e058 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eTRAX™ Needle System Starter Kit |
| Version Model Number | 5451117 |
| Catalog Number | 5451117 |
| 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 |
Device Dimensions
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 Inch |
| Needle Gauge | 18 Gauge |
| Length | 7.7 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436101073 [Primary] |
| GS1 | 20841436118143 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [eTRAX™ Needle System Starter Kit]
| 00841436111065 | Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5) and (7.6 tapered to |
| 00841436111058 | Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5) and (7.6 tapered to |
| 00841436111041 | Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5) and (7.6 tapered to 3. |
| 00841436111034 | Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3. |
| 00841436109468 | Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5) (7.6 tapered to 3.8 |
| 00841436109383 | Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8 |
| 00841436103435 | Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8 |
| 00841436103428 | Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8 |
| 00841436103206 | Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x |
| 00841436102063 | Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8 |
| 00841436101844 | Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8 |
| 00841436101110 | Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x |
| 00841436101103 | Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5), (7.6 tapered to 3.8 x |
| 00841436101073 | Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.6 tapered to 3.8 |
| 00841436100885 | Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.6 tapered to 3.8 |
| 00841436100533 | Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3. |
| 00841436100526 | Reusable non-sterile needle sensor with sterile (14GA x 17cm) needles (5), (7.6 tapered to 3.8 x |
| 00841436100519 | Reusable non-sterile needle sensor with sterile (18GA x 17.7cm) needles (5), (7.8 tapered to 3.8 |
| 00841436100342 | Reusable non-sterile needle sensor with sterile (16GA x 17.7cm) needles (5), (7.8 tapered to 3.8 |
| 20841436118082 | Reusable non-sterile needle sensor with sterile (12GA x 17cm) needles (5) and (7.6 tapered to 3. |
Trademark Results [eTRAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ETRAX 97238952 not registered Live/Pending |
John Daniel Associates, Inc. 2022-01-26 |
 ETRAX 88783597 not registered Live/Pending |
Operation Technology, Inc. 2020-02-03 |
 ETRAX 78241295 not registered Dead/Abandoned |
Terida Systems Inc. 2003-04-23 |
 ETRAX 76010983 not registered Dead/Abandoned |
Sky Desk, Inc. 2000-03-24 |
 ETRAX 75351165 2576923 Live/Registered |
AXIS AB 1997-09-03 |
 ETRAX 72451765 0991947 Dead/Expired |
TELESCIENCES, INC. 1973-03-16 |
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