Primary Device ID | 00890594000889 |
NIH Device Record Key | 82167371-c6a6-412d-93c1-d87b0c3a9865 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Desara |
Version Model Number | CAL-DS01 |
Catalog 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 |
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 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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00890594000872 [Package] Contains: 00890594000896 Package: Box [5 Units] In Commercial Distribution |
GS1 | 00890594000889 [Package] Contains: 00890594000896 Package: Box [1 Units] In Commercial Distribution |
GS1 | 00890594000896 [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 | 2019-10-08 |
Device Publish Date | 2019-09-30 |
00890594000049 | Desara sling system for female stress urinary incontinence. |
00890594000889 | Desara sling system for female stress urinary incontinence. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() DESARA 77127075 3458980 Live/Registered |
Caldera Medical, Inc. 2007-03-09 |