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 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 | 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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