eTRAX™ Needle 610-1615-01
GUDID 00841436103404
Sterile needle, 16GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVCO 16GA needle sensor
CIVCO MEDICAL INSTRUMENTS CO., INC.
Soft-tissue biopsy procedure kit, non-medicated| Primary Device ID | 00841436103404 |
| NIH Device Record Key | 29556ec1-14a3-462d-89d9-54e17d3ab74c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eTRAX™ Needle |
| Version Model Number | 610-1615-01 |
| Catalog Number | 610-1615-01 |
| 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 | true |
| 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 |
Device Dimensions
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
| Needle Gauge | 16 Gauge |
| Length | 15 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841436103404 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092619
FDA Product Code
| IYO | System, imaging, pulsed echo, ultrasonic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
[00841436103404]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-28 |
On-Brand Devices [eTRAX™ Needle]
| 00841436103541 | Sterile needle, 18GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with C |
| 00841436103527 | Sterile needle, 18GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103503 | Sterile needle, 18GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103480 | Sterile needle, 18GA x 10cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103466 | Sterile needle, 18GA x 8cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103442 | Sterile needle, 18GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103404 | Sterile needle, 16GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103381 | Sterile needle, 16GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103367 | Sterile needle, 16GA x 10cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103343 | Sterile needle, 16GA x 8cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103329 | Sterile needle, 16GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103299 | Sterile needle, 14GA x 17cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103275 | Sterile needle, 14GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103251 | Sterile needle, 14GA x 11cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103237 | Sterile needle, 14GA x 9cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103213 | Sterile needle, 14GA x 7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436102520 | Sterile needle, 12GA x 17cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436102421 | Sterile needle, 12GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436102360 | Sterile needle, 12GA x 9cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436102346 | Sterile needle, 12GA x 7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436101851 | Sterile needle, 16GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with C |
| 00841436103510 | Sterile needle, 18GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103497 | Sterile needle, 18GA x 10cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103473 | Sterile needle, 18GA x 8cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103459 | Sterile needle, 18GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103374 | Sterile needle, 16GA x 10cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103350 | Sterile needle, 16GA x 8cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103336 | Sterile needle, 16GA x 6cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103268 | Sterile needle, 14GA x 11cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103244 | Sterile needle, 14GA x 9cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103220 | Sterile needle, 14GA x 7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436102391 | Sterile needle, 12GA x 11cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436102377 | Sterile needle, 12GA x 9cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436102353 | Sterile needle, 12GA x 7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIVC |
| 00841436103558 | Sterile needle, 18GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with C |
| 00841436103534 | Sterile needle, 18GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103411 | Sterile needle, 16GA x 15cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103398 | Sterile needle, 16GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103305 | Sterile needle, 14GA x 17cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436103282 | Sterile needle, 14GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436102537 | Sterile needle, 12GA x 17cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436102438 | Sterile needle, 12GA x 13cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with CIV |
| 00841436101868 | Sterile needle, 16GA x 17.7cm with (7.6 tapered to 3.8 x 147cm) CIV-Flex™ cover for use with C |
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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