Caldera Medical, Inc.

Address:4360 Park Terrace Drive,Westlake Village,CA,91361,US

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Device Description : Desara® Blue SL sling system for female stress urinary incontinence.

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Device Description : Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence ( Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN, PWJ

Prescription Use : Yes

Device Count : 1

Device Description : Desara Blue TVez 2.7mm for the treatment of female stress urinary incontinence ( Desara Blue TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN, PWJ

Prescription Use : Yes

Device Count : 1

Device Description : Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN, PWJ

Prescription Use : Yes

Device Count : 1

Device Description : Desara TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) Desara TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN, PWJ

Prescription Use : Yes

Device Count : 1

Device Description : Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence ( Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN, PWJ

Prescription Use : Yes

Device Count : 1

Device Description : Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) Desara TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN, PWJ

Prescription Use : Yes

Device Count : 1

Device Description : Transobturator Helical, Right Introducer is a surgical mesh instrument to be use Transobturator Helical, Right Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1

Device Description : Desara TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) Desara TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN, PWJ

Prescription Use : Yes

Device Count : 1

Device Description : Transobturator Large Helical, Left Introducer is a surgical mesh instrument to b Transobturator Large Helical, Left Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1