Primary Device ID | 00890594000124 |
NIH Device Record Key | b7f679de-7d69-42d8-9f5b-afd8a92b2fad |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Desara Blue TVez 3.0 |
Version Model Number | CAL-DS01BTV30 |
Company DUNS | 130341956 |
Company Name | Caldera Medical, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com | |
Phone | 1-818-879-6555 |
hello@calderamedical.com |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Special Storage Condition, Specify | Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00890594000124 [Primary] |
OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-08-11 |
Device Publish Date | 2022-08-03 |
00890594000087 | Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed in |
00890594000124 | Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed in |