| Primary Device ID | 07540209956829 |
| NIH Device Record Key | ccc7f27b-db5c-45fa-abb2-aebbc5f1c4fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TissueMapper |
| Version Model Number | 955-MMT-TSMP-ASY |
| Catalog Number | 955-MMT-TSMP-ASY-B |
| Company DUNS | 207008769 |
| Company Name | Claronav 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540209956829 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
[07540209956829]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-23 |
| Device Publish Date | 2025-06-13 |
| 07540209956829 | TissueMapper (Variant B). Optional accessory to MicronMapper used for capturing soft tissue morp |
| 07540209956812 | TissueMapper (Variant A). Optional accessory to MicronMapper used for capturing soft tissue morp |