Desara CAL-DS01

GUDID 00890594000889

Desara sling system for female stress urinary incontinence.

CALDERA MEDICAL, INC.

Stress urinary incontinence surgical mesh, female
Primary Device ID00890594000889
NIH Device Record Key82167371-c6a6-412d-93c1-d87b0c3a9865
Commercial Distribution StatusIn Commercial Distribution
Brand NameDesara
Version Model NumberCAL-DS01
Catalog NumberCAL-DS01
Company DUNS130341956
Company NameCALDERA MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-866-422-5337
Emailinfo@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com
Phone1-818-879-6555
Emailhello@calderamedical.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 AgencyDevice ID
GS100890594000872 [Package]
Contains: 00890594000896
Package: Box [5 Units]
In Commercial Distribution
GS100890594000889 [Package]
Contains: 00890594000896
Package: Box [1 Units]
In Commercial Distribution
GS100890594000896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-08
Device Publish Date2019-09-30

On-Brand Devices [Desara]

00890594000049Desara sling system for female stress urinary incontinence.
00890594000889Desara sling system for female stress urinary incontinence.

Trademark Results [Desara]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DESARA
DESARA
77127075 3458980 Live/Registered
Caldera Medical, Inc.
2007-03-09

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