Caldera Medical, Inc.

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (OTO) (9) Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (OTN) (1)

Premarket Exempt

Clear

Vertessa Lite Strips 4x22cm - 00890594000391 Catalog Number :

Device Description : Vertessa® Lite Strips, 4x22cm polypropylene mesh for sacrocolpopexy

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Vertessa Lite Y-mesh 22x4x3cm - 00890594000421 Catalog Number :

Device Description : Vertessa Lite Y 22x4x3cm polypropylene mesh for sacrocolpopexy

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Vertessa Lite Y 22x5x4cm - 00890594000452 Catalog Number :

Device Description : Vertessa® Lite Y 22x5x4cm polypropylene mesh for sacrocolpopexy .

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Vertessa Lite Y-Mesh 26x4x3cm - 00890594000483 Catalog Number :

Device Description : Vertessa Lite Y 26x4x3cm polypropylene mesh for sacrocolpopexy

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Desara - 00890594000629 Catalog Number :

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

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN

Prescription Use : Yes

Device Count : 1

Desara Blue - 00890594000674 Catalog Number :

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

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Desara Blue OV - 00890594000704 Catalog Number :

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

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Desara Blue Short Suture Sling - 00890594000735 Catalog Number :

Device Description : Desara® Blue Short Suture Sling for female stress urinary incontinence

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Desara SL - 00890594000766 Catalog Number :

Device Description : Desara® 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

Vertessa Lite Y-Mesh 26x5x4cm - 00890594000797 Catalog Number :

Device Description : Vertessa Lite Y 26x5x4cm polypropylene mesh for sacrocolpopexy

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

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