Desara
GUDID 00890594000049
Desara sling system for female stress urinary incontinence.
CALDERA MEDICAL, INC.
Stress urinary incontinence surgical mesh, female| Primary Device ID | 00890594000049 |
| NIH Device Record Key | db9aa2bd-d8d1-47e2-9512-668978fed793 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Desara |
| Version Model Number | CAL-DS01 |
| 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 |
Customer Support Contacts
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@calderamedical.com | |
| Phone | 1-866-422-5337 |
| info@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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00890594000049 [Package] Contains: 00890594000629 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 00890594000612 [Package] Contains: 00890594000629 Package: box [1 Units] In Commercial Distribution |
| GS1 | 00890594000629 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101169
FDA Product Code
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2015-10-30 |
On-Brand Devices [Desara]
| 00890594000049 | Desara sling system for female stress urinary incontinence. |
| 00890594000889 | Desara sling system for female stress urinary incontinence. |
Trademark Results [Desara]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DESARA 77127075 3458980 Live/Registered |
Caldera Medical, Inc. 2007-03-09 |
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