IsoMark™ 3102
GUDID 00714646000934
IsoMark™ Pink Ink
Bionix, LLC
Tattoo ink, dermal| Primary Device ID | 00714646000934 |
| NIH Device Record Key | 818aeb85-3c86-4f4d-b489-197212775aa4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IsoMark™ |
| Version Model Number | UTRT-3102 |
| Catalog Number | 3102 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 25 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com | |
| Phone | +1(800)551-7096 |
| Bionix@bionix.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00714646000910 [Primary] |
| GS1 | 00714646000927 [Primary] |
| GS1 | 00714646000934 [Unit of Use] |
FDA Product Code
| FZZ | MARKER, SKIN |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
[00714646000934]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2022-10-27 |
Devices Manufactured by Bionix, LLC
| 00714646000606 - Igloo Wound Irrigator | 2024-10-03 Wound Irrigation - Sample |
| 10714646000665 - ShotBlocker® | 2024-09-26 5 ct ShotBlocker |
| 10714646000849 - ShotBlocker® | 2024-09-26 ShotBlocker® 2000 ct. Retail |
| 20714646000860 - SafeStraw™ 2 Pack | 2024-09-26 SafeStraw™ 2 Pack |
| 10714646000993 - Opti-Tatt™ Dots | 2024-09-26 Opti-Tatt, Dot, Sheet of 24 |
| 10714646001006 - Opti-Tatt™ Crosshairs | 2024-09-26 Opti-Tatt, Crosshair, Sheet of 24 |
| 10714646001013 - Opti-Tatt™ Field Borders | 2024-09-26 Opti-Tatt, Field Border, Sheet of 24 |
| 10714646001020 - Sample: Opti-Tatt Dots | 2024-09-26 Sample: Opti-Tatt, Dot, Sheet of 3 |
Trademark Results [IsoMark]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ISOMARK 90899878 not registered Live/Pending |
Bionix, LLC 2021-08-24 |
 ISOMARK 75466668 2226246 Dead/Cancelled |
P & L Mark-It, Inc. 1998-04-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.