Coupled™ Fiducial Marker Kit MTNW887711
GUDID 00841439109618
Sterile placement needle (17GA ETW x 20cm) with bone wax, (1.0 x 3mm) soft tissue gold marker couple with 17mm spacer and (1.0 x 3mm) soft tissue gold marker (blue styl-loc) Sterile placement needle (17GA ETW x 20cm) with bone wax and (1.2 x 3mm) soft tissue gold marker (white styl-loc)
MEDTEC, INC.
Imaging lesion localization marker, implantable| Primary Device ID | 00841439109618 |
| NIH Device Record Key | 63037f96-35b4-400f-b9e8-c12727767b8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coupled™ Fiducial Marker Kit |
| Version Model Number | MTNW887711 |
| Catalog Number | MTNW887711 |
| 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 | 00841439109618 [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 |
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
[00841439109618]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| 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 |
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