| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00714646000958 [Primary] |
| FZZ | MARKER, SKIN |
| 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
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2022-10-27 |
| 00714646000736 - OtoClear SprayWash System, Single Use Sample | 2025-09-09 OtoClear SprayWash System, Single Use Sample |
| 10859911004792 - Tabletop Waterpik Adapter Wands | 2025-09-09 Tabletop Waterpik Adapter Wands |
| 00714646001474 - Pelvis Belly Replacement Leg Cushion | 2025-08-29 Pelvis Belly Replacement Leg Cushion |
| 00714646001481 - Pelvis Belly Replacement Arm Rest Cushion | 2025-08-29 Pelvis Belly Replacement Arm Rest Cushion |
| 00714646001498 - Pelvis Belly Replacement Stomach Cushion - Medium | 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Medium |
| 00714646001504 - Pelvis Belly Replacement Face Cushion Assembly | 2025-08-29 Pelvis Belly Replacement Face Cushion Assembly |
| 00714646001511 - Pelvis Belly Replacement Stomach Cushion - Small | 2025-08-29 Pelvis Belly Replacement Stomach Cushion - Small |
| 10714646001099 - Microsuction Stater Pack | 2025-07-16 Microsuction Starter Pack |
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 |