| Primary Device ID | 00860010658932 |
| NIH Device Record Key | 11945150-c0ff-41e4-be94-f14811073023 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FadeMark |
| Version Model Number | Version 1 |
| Company DUNS | 117890787 |
| Company Name | EPHEMERAL SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860010658932 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
[00860010658932]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-08 |
| Device Publish Date | 2025-06-30 |