IsoMark™ Sample, Pink Ink 23102
GUDID 00714646000958
IsoMark™ Sample, Pink Ink
Bionix, LLC
Tattoo ink, dermal| Primary Device ID | 00714646000958 |
| NIH Device Record Key | afd34adb-9662-49b1-98d3-5f5dd06a29e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IsoMark™ Sample, Pink Ink |
| Version Model Number | SP-23102 |
| Catalog Number | 23102 |
| Company DUNS | 117844489 |
| Company Name | Bionix, LLC |
| Device Count | 1 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00714646000958 [Primary] |
FDA Product Code
| FZZ | MARKER, SKIN |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
Radiation Sterilization
[00714646000958]
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
| 10714646000542 - Lighted Ear Curette Demo Pack | 2024-07-18 Lighted Ear Curette Demo Pack |
| 00714646000552 - Sample, Lighted FlexLoop | 2024-07-18 Sample, Lighted FlexLoop |
| 10714646000566 - Sample, Safe Ear Curette Rainbow Pack | 2024-07-18 Sample, Safe Ear Curette Rainbow Pack |
| 10714646000641 - Lighted Ear Curette Demo Pack (monthly mailer) | 2024-07-18 Lighted Ear Curette Demo Pack (monthly mailer) |
| 00714646001085 - Sample, Lighted Suction Handle | 2024-07-18 Sample, Lighted Suction Handle |
| 00714646001252 - Lighted Articulating - Sample | 2024-06-24 Lighted Articulating Curette - Sample |
| 10714646001198 - SecureFoam | 2024-06-10 SecureFoam - Small |
| 10714646001204 - SecureFoam | 2024-06-10 SecureFoam - Medium |
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.