| Primary Device ID | B3960501120 |
| NIH Device Record Key | 85d7f75d-2c0e-4b55-866c-474c09c82fd1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ESI |
| Version Model Number | 05-0112 |
| Company DUNS | 002212793 |
| Company Name | FTT MEDICAL, 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
|---|---|
| HIBCC | B3960501120 [Primary] |
| HJM | Transilluminator, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
[B3960501120]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-18 |
| Device Publish Date | 2016-09-16 |
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