Coupled™ Fiducial Marker Kit MTNW887710
GUDID 00841439109601
Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker coupled with 17mm spacer and (1.0 x 3mm) soft tissue gold marker
MEDTEC, INC.
Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable| Primary Device ID | 00841439109601 |
| NIH Device Record Key | 3c054c85-98cf-40ad-a3f3-2adfe8cfd87f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coupled™ Fiducial Marker Kit |
| Version Model Number | MTNW887710 |
| Catalog Number | MTNW887710 |
| Company DUNS | 103977526 |
| Company Name | MEDTEC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 52 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841439109601 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K071614
FDA Product Code
| IYE | Accelerator, linear, medical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
[00841439109601]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-05-23 |
| Device Publish Date | 2017-08-02 |
On-Brand Devices [Coupled™ Fiducial Marker Kit]
| 00841439109625 | Sterile placement needles (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker c |
| 00841439109618 | Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker co |
| 00841439109601 | Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker co |
| 00841439109595 | Sterile placement needles (18GA ETW x 20cm) with bone wax, (0.8 x 3mm) soft tissue gold marker c |
Trademark Results [Coupled]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COUPLED 86908885 5167992 Live/Registered |
UAMG Content, LLC 2016-02-16 |
 COUPLED 86628043 5060441 Live/Registered |
Ramsperger, Dale 2015-05-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.