eTRAX™ Needle Sensor 667-158
GUDID 00841436111096
Reusable non-sterile needle sensor for use with Aurora trackers
CIVCO MEDICAL INSTRUMENTS CO., INC.
Patient positioning sensor 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 | 00841436111096 |
| NIH Device Record Key | aeb6a2f5-386c-487c-9322-50db1f31867b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eTRAX™ Needle Sensor |
| Version Model Number | 667-158 |
| Catalog Number | 667-158 |
| 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 | false |
| 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
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 16 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436111096 [Primary] |
| GS1 | 20841436118136 [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 | 2018-09-26 |
| Device Publish Date | 2017-08-22 |
On-Brand Devices [eTRAX™ Needle Sensor]
| 00841436111102 | Reusable non-sterile needle sensor for use with Aurora trackers |
| 00841436111096 | Reusable non-sterile needle sensor for use with Aurora trackers |
| 00841436111089 | Reusable non-sterile needle sensor for use with Aurora trackers |
| 00841436111072 | Reusable non-sterile needle sensor for use with Aurora trackers |
| 00841436101141 | Reusable non-sterile needle sensor for use with 3D Guidance driveBAY™ or trakSTAR™ trackers |
| 00841436101134 | Reusable non-sterile needle sensor for use with 3D Guidance driveBAY™ or trakSTAR™ trackers |
| 00841436101127 | Reusable non-sterile needle sensor for use with 3D Guidance driveBAY™ or trakSTAR™ trackers |
| 00841436100977 | Reusable non-sterile needle sensor for use with 3D Guidance driveBAY™ or trakSTAR™ trackers |
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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