eTRAX™ Needle Sensor 667-156
GUDID 00841436111072
Reusable non-sterile needle sensor for use with Aurora trackers
CIVCO MEDICAL INSTRUMENTS CO., INC.
Patient positioning sensor| Primary Device ID | 00841436111072 |
| NIH Device Record Key | ffceb01a-846a-4b22-99b7-29fe1162e91e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eTRAX™ Needle Sensor |
| Version Model Number | 667-156 |
| Catalog Number | 667-156 |
| 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
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
| Needle Gauge | 12 Gauge |
| Length | 7.4 Inch |
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 | 00841436111072 [Primary] |
| GS1 | 20841436118075 [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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