Desara
GUDID 00890594000049
Desara sling system for female stress urinary incontinence.
CALDERA MEDICAL, INC.
Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer| 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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