Desara One

GUDID 00890594000957

Single Incision Sling System (1/box)

CALDERA MEDICAL, INC.

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Primary Device ID00890594000957
NIH Device Record Keydd034f73-2acb-4f40-b1da-7828f505ae26
Commercial Distribution StatusIn Commercial Distribution
Brand NameDesara One
Version Model NumberCAL-DS2111
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
Phone1.866.422.5337
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

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.
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
GS100890594000957 [Primary]
GS100890594000964 [Package]
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-04
Device Publish Date2020-02-25

On-Brand Devices [Desara One ]

00890594000971Single Incision Sling System (3/box)
00890594000957Single Incision Sling System (1/box)
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